Hydralazine Hydrochloride

Exelan Pharmaceuticals Inc.
Human Prescription Drug
NDC 76282-310

Hydralazine Hydrochloride is a human prescription drug labeled by 'Exelan Pharmaceuticals Inc.'. National Drug Code (NDC) number for Hydralazine Hydrochloride is 76282-310. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Hydralazine Hydrochloride drug includes Hydralazine Hydrochloride - 25 mg/1 . The currest status of Hydralazine Hydrochloride drug is Active.

Drug Information:

Drug NDC:	76282-310
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:	Hydralazine Hydrochloride
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:	Hydralazine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Exelan Pharmaceuticals Inc.
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:	HYDRALAZINE HYDROCHLORIDE - 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:	20 May, 2016
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:	ANDA090255
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:	Exelan Pharmaceuticals Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	905199 905222 905225 905395
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.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0376282309019 0376282310015 0376282311012 0376282312019
UPC stands for Universal Product Code.
UNII:	FD171B778Y
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:	Arteriolar Vasodilation [PE] Arteriolar Vasodilator [EPC]
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
76282-310-01	100 TABLET in 1 BOTTLE (76282-310-01)	20 May, 2016	N/A	No
76282-310-10	1000 TABLET in 1 BOTTLE (76282-310-10)	20 May, 2016	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

Hydralazine

Hydralazine Hydrochloride

Tablet
Nivagen Pharmaceuticals, Inc.
NDC: 75834-126

Hydralazine Hydrochloride

Tablet
Exelan Pharmaceuticals Inc.
NDC: 76282-310

Hydralazine Hydrochloride

Injection
Akorn
NDC: 17478-934

Hydralazine Hydrochloride

Tablet, Film Coated
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC: 23155-004

Product Elements:

Hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose cellulose, microcrystalline sodium starch glycolate type a potato fd&c yellow no. 6 stearic acid orange colored ig;309 hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose cellulose, microcrystalline sodium starch glycolate type a potato fd&c yellow no. 6 stearic acid orange colored ig;310 hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose cellulose, microcrystalline sodium starch glycolate type a potato fd&c yellow no. 6 stearic acid orange coloured ig;311 hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose cellulose, microcrystalline sodium starch glycolate type a potato fd&c yellow no. 6 stearic acid orange cloured ig;312

Indications and Usage:

1 indications and usage essential hypertension, alone or as an adjunct.

Warnings:

Warnings in a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. in such patients hydralazine should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. long-term treatment with steroids may be necessary. (see precautions, laboratory tests .)

Dosage and Administration:

2 dosage and administration initiate therapy in gradually increasing dosages; adjust according to individual response. start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. for the second and subsequent weeks, increase dosage to 50 mg four times daily. for maintenance, adjust dosage to the lowest effective levels. the incidence of toxic reactions, particularly the l.e. cell syndrome, is high in the group of patients receiving large doses of hydralazine hydrochloride tablets. in a few resistant patients, up to 300 mg of hydralazine hydrochloride tablets daily may be required for a significant antihypertensive effect. in such cases, a lower dosage of hydralazine hydrochloride tablets combined with a thiazide and/or reserpine or a beta blocker may be considered. however, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.

Contraindications:

Contraindications hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.

Adverse Reactions:

Adverse reactions adverse reactions with hydralazine are usually reversible when dosage is reduced. however, in some cases it may be necessary to discontinue the drug. the following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. common headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris less frequent digestive constipation, paralytic ileus. cardiovascular hypotension, paradoxical pressor response, edema. respiratory dyspnea. neurologic peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. genitourinary difficulty in urination hematologic blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. hypersensitive reactions rash, urticaria, pruritu Read more...

s, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. other nasal congestion, flushing, lacrimation, conjunctivitis.

Overdosage:

Overdosage acute toxicity no deaths due to acute poisoning have been reported. highest known dose survived: adults, 10 g orally. oral ld 50 in rats: 173 and 187 mg/kg. signs and symptoms signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock. treatment there is no specific antidote. the gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. an activated charcoal slurry may be instilled if conditions permit. these manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock. support of the cardiovascular system is of primary importance. shock should be treated with plasma expanders. if possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia. tachycardia responds to beta blockers. digitalization may be necessary, and renal function should be monitored and supported as required. no experience has been reported with extracorporeal or peritoneal dialysis.

Description:

Description hydralazine hydrochloride tablets usp, is an antihypertensive, for oral administration. its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: hydralazine hydrochloride usp is a white to off-white, odorless crystalline powder. it is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. it melts at about 275Â°c, with decomposition, and has a molecular weight of 196.64. each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, usp. tablets also contain microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, fd&c yellow #6 and stearic acid.

Clinical Pharmacology:

Clinical pharmacology although the precise mechanism of action of hydralazine is not fully understood, the major effects are on the cardiovascular system. hydralazine apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. hydralazine, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state. the peripheral vasodilating effect of hydralazine results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. the preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. hydralazine usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal ju Read more...

xtaglomerular cells in response to reflex sympathetic discharge. this increase in renin activity leads to the production of angiotensin ii, which then causes stimulation of aldosterone and consequent sodium reabsorption. hydralazine also maintains or increases renal and cerebral blood flow. hydralazine is rapidly absorbed after oral administration, and peak plasma levels are reached at 1 to 2 hours. plasma levels of apparent hydralazine decline with a half-life of 3 to 7 hours. binding to human plasma protein is 87%. plasma levels of hydralazine vary widely among individuals. hydralazine is subject to polymorphic acetylation; slow acetylators generally have higher plasma levels of hydralazine and require lower doses to maintain control of blood pressure. hydralazine undergoes extensive hepatic metabolism; it is excreted mainly in the form of metabolites in the urine.

How Supplied:

How supplied hydralazine hydrochloride tablets usp are available as: 10 mg - orange, round, biconvex tablets debossed with 'ig' on one side and "309" on the other, supplied in bottles of 100 (ndc 76282-309-01) and 1000 (ndc 76282-309-10). 25 mg - orange, round, biconvex tablets debossed with 'ig' on one side and "310" on the other, supplied in bottles of 100 (ndc 76282-310-01) and 1000 (ndc 76282-310-10). 50 mg - orange, round, biconvex tablets debossed with 'ig' on one side and "311" on the other, supplied in bottles of 100 (ndc 76282-311-01) and 1000 (ndc 76282-311-10). 100 mg -orange, round, biconvex tablets debossed with 'ig' on one side and "312" on the other, supplied in bottles of 100 (ndc 76282-312-01). store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. dispense in a tight, light-resistant container as defined in the usp, with a child-resistant closure (as required). keep this and all medications out of the reach of children. manufactured by: Read more...

invagen pharmaceuticals, inc. (a subsidiary of cipla ltd.) hauppauge, ny 11788 manufactured for: exelan pharmaceuticals, inc., boca raton, fl 33432 rev: 06/20 barcode: 312-06-2020 rx only

Package Label Principal Display Panel:

Principal display panel ndc 76282-309-01 hydralazine hydrochloride tablets usp 10mg rx only 100 tablets exelan pharmaceuticals,inc. principal display panel ndc 76282-310-01 hydralazine hydrochloride tablets usp 25mg rx only 100 tablets exelan pharmaceuticals,inc. principal display panel ndc 76282-311-01 hydralazine hydrochloride tablets usp 50mg rx only 100 tablets exelan pharmaceuticals,inc. principal display panel ndc 76282-312-01 hydralazine hydrochloride tablets usp 100mg rx only 100 tablets exelan pharmaceuticals,inc. chemical structure 1mg-100 mm3 mm4 mm5

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.