Hydrochlorothiazide

Aphena Pharma Solutions - Tennessee, Llc
Human Prescription Drug
NDC 71610-488

Hydrochlorothiazide is a human prescription drug labeled by 'Aphena Pharma Solutions - Tennessee, Llc'. National Drug Code (NDC) number for Hydrochlorothiazide is 71610-488. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Hydrochlorothiazide drug includes Hydrochlorothiazide - 25 mg/1 . The currest status of Hydrochlorothiazide drug is Active.

Drug Information:

Drug NDC:	71610-488
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Hydrochlorothiazide
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Hydrochlorothiazide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Aphena Pharma Solutions - Tennessee, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	HYDROCHLOROTHIAZIDE - 25 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	16 Mar, 2007
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA040702
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Aphena Pharma Solutions - Tennessee, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	310798
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
NUI:	N0000175359 N0000175419 M0471776
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	0J48LPH2TH
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Thiazide Diuretic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Diuresis [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Thiazides [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Increased Diuresis [PE] Thiazide Diuretic [EPC] Thiazides [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
71610-488-15	15 TABLET in 1 BOTTLE, PLASTIC (71610-488-15)	10 Nov, 2020	N/A	No
71610-488-30	30 TABLET in 1 BOTTLE, PLASTIC (71610-488-30)	10 Nov, 2020	N/A	No
71610-488-45	45 TABLET in 1 BOTTLE, PLASTIC (71610-488-45)	10 Nov, 2020	N/A	No
71610-488-53	60 TABLET in 1 BOTTLE, PLASTIC (71610-488-53)	10 Nov, 2020	N/A	No
71610-488-60	90 TABLET in 1 BOTTLE, PLASTIC (71610-488-60)	10 Nov, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Hydrochlorothiazide hydrochlorothiazide fd&c yellow no. 6 cellulose, microcrystalline anhydrous lactose sodium starch glycolate type a corn stearic acid magnesium stearate hydrochlorothiazide hydrochlorothiazide peach round ep;131

Indications and Usage:

Indications and usage hydrochlorothiazide tablets usp are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. hydrochlorothiazide tablets usp have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. hydrochlorothiazide tablets usp are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. use in pregnancy routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical conse Read more...

quences of pregnancy. thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see precautions, pregnancy ). dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. during normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. however, it may be associated with edema, rarely generalized edema. if such edema causes discomfort, increased recumbency will often provide relief. rarely this edema may cause extreme discomfort which is not relieved by rest. in these instances, a short course of diuretic therapy may provide relief and be appropriate.

Warnings:

Warnings use with caution in severe renal disease. in patients with renal disease, thiazides may precipitate azotemia. cumulative effects of the drug may develop in patients with impaired renal function. thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. thiazides may add to or potentiate the action of other antihypertensive drugs. sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. the possibility of exacerbation or activation of systemic lupus erythematosus has been reported. lithium generally should not be given with diuretics (see precautions, drug interactions ). acute myopia and secondary angle-closure glaucoma hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. symptoms include acute onset of dec Read more...

reased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation., untreated acute angle-closure glaucoma can lead to permanent vision loss. the primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Dosage and Administration:

Dosage and administration therapy should be individualized according to patient response. use the smallest dosage necessary to achieve the required response.

Adults for edema the usual adult dosage is 25mg to 100 mg daily as a single or divided dose. many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. with an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur. for control of hypertension the usual initial dose in adults is 25 mg daily given as a single dose. the dose may be increased to 50 mg daily, given as a single or two divided doses. doses above 50 mg are often associated with marked reductions in serum potassium (see also precautions ). patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.

Infants and children for diuresis and for control of hypertension the usual pediatric dosage is 0.5 mg to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. in infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required. (see precautions, pediatric use )

Contraindications:

Contraindications anuria. hypersensitivity to this product or to other sulfonamide-derived drugs.

Adverse Reactions:

Adverse reactions the following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. body as a whole weakness. cardiovascular hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). digestive pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. hematologic aplastic anemia, agranulocytosis, leucopenia, hemolytic anemia, thrombocytopenia. hypersensitivity anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. metabolic electrolyte imbalance (see precautions ), hyperglycemia, glycosuria, hyperuricemia musculoskeletal muscle spasm. nervous system/psychiatric vertigo, paresthesias, dizziness, headache, restlessness. renal Read more...

renal failure, renal dysfunction, interstitial nephritis (see warnings ) skin erythema multiforme including stevens-johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. special senses transient blurred vision, xanthopsia. urogenital impotence. whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn. call your doctor for medical advice about side effects. you may report side effects to the fda at 1-800-fda-1088 or leading pharma, llc at 1-844-740-7500.

Body as a whole weakness. cardiovascular hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). digestive pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. hematologic aplastic anemia, agranulocytosis, leucopenia, hemolytic anemia, thrombocytopenia. hypersensitivity anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. metabolic electrolyte imbalance (see precautions ), hyperglycemia, glycosuria, hyperuricemia musculoskeletal muscle spasm. nervous system/psychiatric vertigo, paresthesias, dizziness, headache, restlessness. renal renal failure, renal dysfunction, interstitial nephritis (see warnings ) skin erythema multiforme including stevens-johnson syndrome, exfoli Read more...

ative dermatitis including toxic epidermal necrolysis, alopecia. special senses transient blurred vision, xanthopsia. urogenital impotence. whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn. call your doctor for medical advice about side effects. you may report side effects to the fda at 1-800-fda-1088 or leading pharma, llc at 1-844-740-7500.

Overdosage:

Overdosage the most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. if digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. in the event of overdosage, symptomatic and supportive measures should be employed. emesis should be induced or gastric lavage performed. correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. if required, give oxygen or artificial respiration for respiratory impairment. the degree to which hydrochlorothiazide is removed by hemodialysis has not been established. the oral ld 50 of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

Description:

Description hydrochlorothiazide usp is a diuretic and antihypertensive. it is the 3,4-dihydro derivative of chlorothiazide. it is chemically designated as 6-chloro-3,4-dihydro-2 h -1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula: hydrochlorothiazide usp is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg of hydrochlorothiazide usp respectively. in addition, each tablet contains the following inactive ingredients: fd&c yellow #6, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid. chem structure

Clinical Pharmacology:

Clinical pharmacology the mechanism of the antihypertensive effect of thiazides is unknown. hydrochlorothiazide does not usually affect normal blood pressure. hydrochlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption. at maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy. hydrochlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. natriuresis may be accompanied by some loss of potassium and bicarbonate. after oral use diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to12 hours.

Pharmacokinetics and metabolism hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney. when plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.6 and 14.8 hours. at least 61% of the oral dose is eliminated unchanged within 24 hours. hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.

How Supplied:

How supplied hydrochlorothiazide tablets usp, 12.5 mg are available as peach color, round, flat face, beveled edge tablets, debossed âepâ above and â155â below on one side, and plain on the other side containing 12.5 mg of hydrochlorothiazide usp, packaged in bottles of 100 (ndc 51407-330-01) tablets. hydrochlorothiazide tablets usp, 25 mg are available as peach color, round, flat face, beveled edge bisected tablets, debossed "ep" above bisect and "131" below bisect on one side and plain on the other side containing 25 mg of hydrochlorothioazide usp, packaged in bottles of 100 (ndc 51407-331-01), 1000 (ndc 51407-331-10) and 90 (ndc 51407-331-90) tablets. hydrochlorothiazide tablets usp, 50 mg are available as peach color, round, flat face, beveled edge, bisected tablets, debossed "ep" above bisect and "130" below bisect on one side and plain on the other side containing 50 mg of hydrochlorothiazide usp, packaged in bottles of 100 (ndc 51407-332-01), 1000 (ndc 51407- Read more...

332-10), and 90 (ndc 51407-332-90) tablets. dispense in a well-closed container as defined in the usp, with a child-resistant closure (as required). store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. keep this and all medications out of the reach of children. manufactured by: leading pharma, llc fairfield, nj 07004 rev.02 05/17 marketed/packaged by: gsms, inc. camarillo, ca usa 93012

Package Label Principal Display Panel:

Principal display panel - 25 mg ndc 71610-488 - hydrochlorothiazide, usp 25 mg tablets - rx only bottle label 25 mg

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.