Benazepril Hydrochloride

BENAZEPRIL HYDROCHLORIDE- benazepril hydrochloride tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1148-9

Benazepril Hydrochloride Tablets, 5 mg

90 Tablets

Rx only

Benazepril Hydrochloride Tablets
(click image for full-size original)

NDC 70771-1149-9

Benazepril Hydrochloride Tablets, 10 mg

90 Tablets

Rx only

Benazepril Hydrochloride Tablets
(click image for full-size original)

NDC 70771-1150-9

Benazepril Hydrochloride Tablets, 20 mg

90 Tablets

Rx only

Benazepril Hydrochloride Tablets
(click image for full-size original)

NDC 70771-1151-9

Benazepril Hydrochloride Tablets, 40 mg

90 Tablets

Rx only

Benazepril Hydrochloride Tablets
(click image for full-size original)
BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1148
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FERRIC OXIDE YELLOW
HYDROGENATED COTTONSEED OIL
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SHELLAC
FERROSOFERRIC OXIDE
LECITHIN, SOYBEAN
SILICON
CROSPOVIDONE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code B1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1148-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1148-1 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1148-0 1000 TABLET, FILM COATED in 1 BOTTLE None
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 coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1149
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SHELLAC
LECITHIN, SOYBEAN
SILICON
FERROSOFERRIC OXIDE
CROSPOVIDONE
POLYETHYLENE GLYCOL, UNSPECIFIED
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 Multilevel Packaging
1 NDC:70771-1149-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1149-1 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1149-0 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1149-4 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1149-2)
4 NDC:70771-1149-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1149-4)
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 coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SHELLAC
LECITHIN, SOYBEAN
FERROSOFERRIC OXIDE
SILICON
CROSPOVIDONE
POLYETHYLENE GLYCOL, UNSPECIFIED
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 Multilevel Packaging
1 NDC:70771-1150-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1150-1 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1150-0 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1150-4 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1150-2)
4 NDC:70771-1150-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1150-4)
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 coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1151
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SHELLAC
FERROSOFERRIC OXIDE
LECITHIN, SOYBEAN
SILICON
CROSPOVIDONE
POLYETHYLENE GLYCOL, UNSPECIFIED
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 Multilevel Packaging
1 NDC:70771-1151-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1151-1 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1151-0 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1151-4 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1151-2)
4 NDC:70771-1151-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1151-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078848 11/13/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1148), ANALYSIS (70771-1149), ANALYSIS (70771-1150), ANALYSIS (70771-1151), MANUFACTURE (70771-1148), MANUFACTURE (70771-1149), MANUFACTURE (70771-1150), MANUFACTURE (70771-1151)

Revised: 08/2020 Cadila Healthcare Limited

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