Fosinopril Sodium (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 10 mg

NDC 76282-200-90

FOSINOPRIL SODIUM Tablets, USP

10 mg

EXELAN PHARMACEUTICALS, INC.

Rx Only 90 Tablets

10 mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 20 mg

NDC 76282-201-90

FOSINOPRIL SODIUM Tablets, USP

20 mg

EXELAN PHARMACEUTICALS, INC.

Rx Only 90 Tablets

20 mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 40 mg

NDC 76282-202-90

FOSINOPRIL SODIUM Tablets, USP

40 mg

EXELAN PHARMACEUTICALS, INC.

Rx Only 90 Tablets

40 mg
(click image for full-size original)
FOSINOPRIL SODIUM fosinopril sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSINOPRIL SODIUM (FOSINOPRILAT) FOSINOPRIL SODIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code IG;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-200-90 90 TABLET in 1 BOTTLE None
2 NDC:76282-200-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077222 06/21/2005
FOSINOPRIL SODIUM fosinopril sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSINOPRIL SODIUM (FOSINOPRILAT) FOSINOPRIL SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code IG;201
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-201-90 90 TABLET in 1 BOTTLE None
2 NDC:76282-201-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077222 06/21/2005
FOSINOPRIL SODIUM fosinopril sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-202
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSINOPRIL SODIUM (FOSINOPRILAT) FOSINOPRIL SODIUM 40 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code IG;202
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-202-90 90 TABLET in 1 BOTTLE None
2 NDC:76282-202-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077222 06/21/2005
Labeler — Exelan Pharmaceuticals, Inc. (967795266)
Registrant — InvaGen Pharmaceuticals, Inc. (165104469)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals, Inc. 165104469 MANUFACTURE (76282-200), MANUFACTURE (76282-201), MANUFACTURE (76282-202), ANALYSIS (76282-200), ANALYSIS (76282-201), ANALYSIS (76282-202)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals, Inc. 080334903 analysis (76282-200), analysis (76282-201), analysis (76282-202), pack (76282-200), pack (76282-201), pack (76282-202)

Revised: 03/2023 Exelan Pharmaceuticals, Inc.

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