Hydralazine Hydrochloride
Cardinal Health 107, Llc
Human Prescription Drug
NDC 55154-7293Hydralazine Hydrochloride is a human prescription drug labeled by 'Cardinal Health 107, Llc'. National Drug Code (NDC) number for Hydralazine Hydrochloride is 55154-7293. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Hydralazine Hydrochloride drug includes Hydralazine Hydrochloride - 10 mg/1 . The currest status of Hydralazine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 55154-7293 |
| 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: | Cardinal Health 107, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| 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 - 10 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: | 14 May, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | ANDA086242 |
| 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: | Cardinal Health 107, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 905199
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. |
| UPC: | 0055154729406
0055154729307
|
| 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 |
|---|
| 55154-7293-0 | 10 BLISTER PACK in 1 BAG (55154-7293-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 14 May, 2015 | 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. |
Product Elements:
Hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose microcrystalline cellulose starch, corn magnesium stearate mineral oil titanium dioxide sodium lauryl sulfate fd&c red no. 40 hypromellose, unspecified hp;1 hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose microcrystalline cellulose starch, corn magnesium stearate mineral oil titanium dioxide sodium lauryl sulfate fd&c red no. 40 hypromellose, unspecified hp;2 hydralazine hydrochloride hydralazine hydrochloride hydralazine hydrochloride hydralazine anhydrous lactose microcrystalline cellulose starch, corn magnesium stearate mineral oil titanium dioxide sodium lauryl sulfate fd&c red no. 40 hypromellose, unspecified hp;3
Indications and Usage:
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 .)
Contraindications:
Contraindications hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
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. 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. in a few resistant patients, up to 300 mg of hydralazine daily may be required for a significant antihypertensive effect. in such cases, a lower dosage of hydralazine 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. how supplied hydralazine hydrochloride tablets, usp 10 mg - round, convex, pink film coated tablet engraved with hp above 1 on one side and plain on the other side overbagged with 10 tablets per bag, ndc 55154-7293-0 25 mg - round, convex, pink film coated tablet engraved with hp above 2 on one side and plain on the other side overbagged with 10 tablets per bag, ndc 55154-7294-0 50 mg - round, convex, pink film coated tablet engraved with hp above 3 on one side and plain on the other side overbagged with 10 tablets per bag, ndc 55154-7295-0 dispense in a tight, light-resistant container as defined in the usp. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. distributed by: avet pharmaceuticals inc. east brunswick, nj 08816 1-866-901-drug (3784) 51u000000172us04 distributed by: cardinal health dublin, oh 43017 l54966170721 l54966250621 l54966330321 revised: 02/2020
Description:
Description hydralazine hydrochloride, 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 275°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 fd&c red #40/allura red ac aluminum lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. image
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.
Package Label Principal Display Panel:
Package/label display panel hydralazine hydrochloride tablets, usp 10 mg 10 tablets bag label
Package/label display panel hydralazine hydrochloride tablets, usp 25 mg 10 tablet bag label
Package/label display panel hydralazine hydrochloride tablets, usp 50 mg 10 tablets bag label