Application Nr Approved Date Route Status External Links
ANDA076118 2004-02-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Benazepril Hydrochloride Tablets, Usp Are Indicated For The Treatment Of Hypertension. Benazepril Hydrochloride Tablets May Be Used Alone Or In Combination With Thiazide Diuretics. In Using Benazepril Consideration Should Be Given To The Fact That Another Angiotensin-Converting Enzyme Inhibitor, Captopril, Has Caused Agranulocytosis, Particularly In Patients With Renal Impairment Or Collagen-Vascular Disease. Available Data Are Insufficient To Show That Benazepril Hydrochloride Tablets Do Not Have A Similar Risk (see Warnings). Black Patients Receiving Ace Inhibitors Have Been Reported To Have A Higher Incidence Of Angioedema Compared To Nonblacks. It Should Also Be Noted That In Controlled Clinical Trials Ace Inhibitors Have An Effect On Blood Pressure That Is Less In Black Patients Than In Nonblacks.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE ZINC3781943

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