Label: BENAZEPRIL HYDROCHLORIDE tablet, film coated
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NDC Code(s):
70771-1148-0,
70771-1148-1,
70771-1148-9,
70771-1149-0, view more70771-1149-1, 70771-1149-2, 70771-1149-4, 70771-1149-9, 70771-1150-0, 70771-1150-1, 70771-1150-2, 70771-1150-4, 70771-1150-9, 70771-1151-0, 70771-1151-1, 70771-1151-2, 70771-1151-4, 70771-1151-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1148 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703) BENAZEPRIL HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON (UNII: Z4152N8IUI) CROSPOVIDONE (UNII: 2S7830E561) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code B1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1148-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 2 NDC:70771-1148-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 3 NDC:70771-1148-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078848 11/13/2017 BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1149 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703) BENAZEPRIL HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON (UNII: Z4152N8IUI) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CROSPOVIDONE (UNII: 2S7830E561) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code B2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1149-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 2 NDC:70771-1149-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 3 NDC:70771-1149-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 4 NDC:70771-1149-4 100 in 1 CARTON 11/13/2017 4 NDC:70771-1149-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078848 11/13/2017 BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1150 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703) BENAZEPRIL HYDROCHLORIDE 20 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON (UNII: Z4152N8IUI) CROSPOVIDONE (UNII: 2S7830E561) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code B3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1150-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 2 NDC:70771-1150-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 3 NDC:70771-1150-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 4 NDC:70771-1150-4 100 in 1 CARTON 11/13/2017 4 NDC:70771-1150-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078848 11/13/2017 BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1151 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703) BENAZEPRIL HYDROCHLORIDE 40 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON (UNII: Z4152N8IUI) CROSPOVIDONE (UNII: 2S7830E561) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code B4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1151-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 2 NDC:70771-1151-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 3 NDC:70771-1151-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2017 4 NDC:70771-1151-4 100 in 1 CARTON 11/13/2017 4 NDC:70771-1151-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078848 11/13/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1148, 70771-1149, 70771-1150, 70771-1151) , MANUFACTURE(70771-1148, 70771-1149, 70771-1150, 70771-1151)
