Quinapril (Page 6 of 6)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (90 Tablet Bottle)

NDC 65862-617-90
Rx only
Quinapril
Tablets, USP
5 mg
AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (90 Tablet Bottle)

NDC 65862-618-90
Rx only
Quinapril
Tablets, USP
10 mg AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (90 Tablet Bottle)

NDC 65862-619-90 Rx only
Quinapril Tablets, USP
20 mg
AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg (90 Tablet Bottle)

NDC 65862-620-90
Rx only
Quinapril Tablets, USP
40 mg AUROBINDO 90 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg (90 Tablet Bottle)
(click image for full-size original)
QUINAPRIL quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-617
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRILAT) QUINAPRIL 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM CARBONATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score 2 pieces
Shape OVAL Size 6mm
Flavor Imprint Code 5;2;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-617-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-617-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-617-99 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-617-55 15000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-617-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-617-10)
5 NDC:65862-617-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-617-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202725 04/29/2013
QUINAPRIL quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-618
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRILAT) QUINAPRIL 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM CARBONATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape TRIANGLE Size 9mm
Flavor Imprint Code 53;H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-618-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-618-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-618-99 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-618-55 15000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-618-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-618-10)
5 NDC:65862-618-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-618-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202725 04/29/2013
QUINAPRIL quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-619
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRILAT) QUINAPRIL 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM CARBONATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code D;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-619-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-619-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-619-99 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-619-19 10000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-619-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-619-10)
5 NDC:65862-619-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-619-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202725 04/29/2013
QUINAPRIL quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-620
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRILAT) QUINAPRIL 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM CARBONATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 15mm
Flavor Imprint Code D;17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-620-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-620-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-620-99 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-620-39 3000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65862-620-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-620-10)
5 NDC:65862-620-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-620-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202725 04/29/2013
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 650844777 ANALYSIS (65862-617), ANALYSIS (65862-618), ANALYSIS (65862-619), ANALYSIS (65862-620), MANUFACTURE (65862-617), MANUFACTURE (65862-618), MANUFACTURE (65862-619), MANUFACTURE (65862-620)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-617), ANALYSIS (65862-618), ANALYSIS (65862-619), ANALYSIS (65862-620), MANUFACTURE (65862-617), MANUFACTURE (65862-618), MANUFACTURE (65862-619), MANUFACTURE (65862-620)

Revised: 07/2020 Aurobindo Pharma Limited

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