NDC Code(s) : 55648-902-01, 55648-902-02, 55648-902-05, 55648-903-01, 55648-903-02, 55648-903-05, 55648-904-01, 55648-904-02, 55648-904-05, 55648-905-01, 55648-905-04
Packager : Wockhardt Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CAPTOPRILCAPTOPRIL TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-902
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPTOPRIL(UNII: 9G64RSX1XD)
(CAPTOPRIL - UNII:9G64RSX1XD) 		CAPTOPRIL12.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
PALMITIC ACID(UNII: 2V16EO95H1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (flat bevelled-edge) Size 5 mm
Flavor Imprint Code W;902
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55648-902-01100 in 1 BOTTLE
2NDC:55648-902-021000 in 1 BOTTLE
3NDC:55648-902-0520000 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074532 03/28/1997

LABELER - Wockhardt Limited(650069115)

REGISTRANT - Wockhardt Limited(650069115)

Establishment
Name Address ID/FEI Business Operations
Wockhardt Limited 916489953 Analysis(55648-902, 55648-903, 55648-904, 55648-905), Manufacture(55648-902, 55648-903, 55648-904, 55648-905), Label(55648-902, 55648-903, 55648-904, 55648-905), Pack(55648-902, 55648-903, 55648-904, 55648-905)

INGREDIENTS AND APPEARANCE

CAPTOPRILCAPTORPIL TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-903
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPTOPRIL(UNII: 9G64RSX1XD)
(CAPTOPRIL - UNII:9G64RSX1XD) 		CAPTOPRIL25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
PALMITIC ACID(UNII: 2V16EO95H1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score 4 pieces
Shape ROUND (flat bevelled-edge) Size 7 mm
Flavor Imprint Code W;903
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55648-903-01100 in 1 BOTTLE
2NDC:55648-903-021000 in 1 BOTTLE
3NDC:55648-903-0510000 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074532 03/28/1997

LABELER - Wockhardt Limited(650069115)

REGISTRANT - Wockhardt Limited(650069115)

Establishment
Name Address ID/FEI Business Operations
Wockhardt Limited 916489953 Analysis(55648-902, 55648-903, 55648-904, 55648-905), Manufacture(55648-902, 55648-903, 55648-904, 55648-905), Label(55648-902, 55648-903, 55648-904, 55648-905), Pack(55648-902, 55648-903, 55648-904, 55648-905)

INGREDIENTS AND APPEARANCE

CAPTOPRILCAPTORPIL TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-904
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPTOPRIL(UNII: 9G64RSX1XD)
(CAPTOPRIL - UNII:9G64RSX1XD) 		CAPTOPRIL50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
PALMITIC ACID(UNII: 2V16EO95H1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (flat bevelled-edge) Size 8 mm
Flavor Imprint Code W;904
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55648-904-01100 in 1 BOTTLE
2NDC:55648-904-021000 in 1 BOTTLE
3NDC:55648-904-055000 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074532 03/28/1997

LABELER - Wockhardt Limited(650069115)

REGISTRANT - Wockhardt Limited(650069115)

Establishment
Name Address ID/FEI Business Operations
Wockhardt Limited 916489953 Analysis(55648-902, 55648-903, 55648-904, 55648-905), Manufacture(55648-902, 55648-903, 55648-904, 55648-905), Label(55648-902, 55648-903, 55648-904, 55648-905), Pack(55648-902, 55648-903, 55648-904, 55648-905)

INGREDIENTS AND APPEARANCE

CAPTOPRILCAPTORPIL TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55648-905
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPTOPRIL(UNII: 9G64RSX1XD)
(CAPTOPRIL - UNII:9G64RSX1XD) 		CAPTOPRIL100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
PALMITIC ACID(UNII: 2V16EO95H1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (flat bevelled-edge) Size 11 mm
Flavor Imprint Code W;905
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55648-905-01100 in 1 BOTTLE
2NDC:55648-905-044000 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074532 03/28/1997

LABELER - Wockhardt Limited(650069115)

REGISTRANT - Wockhardt Limited(650069115)

Establishment
Name Address ID/FEI Business Operations
Wockhardt Limited 916489953 Analysis(55648-902, 55648-903, 55648-904, 55648-905), Manufacture(55648-902, 55648-903, 55648-904, 55648-905), Label(55648-902, 55648-903, 55648-904, 55648-905), Pack(55648-902, 55648-903, 55648-904, 55648-905)

PRINCIPAL DISPLAY PANEL

DRUG: Captopril

GENERIC: Captopril

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-902-01

STRENGTH: 12.5 mg

COLOR: White

SHAPE: Round

SCORE: Scored

SIZE: 5 mm

IMPRINT: W;902

QTY: 100 Tablets

Label

DRUG: Captopril

GENERIC: Captopril

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-903-02

STRENGTH: 25 mg

COLOR: White

SHAPE: Round

SCORE: Scored

SIZE: 7 mm

IMPRINT: W;903

QTY: 1000 Tablets

Label

DRUG: Captopril

GENERIC: Captopril

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-904-01

STRENGTH: 50 mg

COLOR: White

SHAPE: Round

SCORE: Scored

SIZE: 8 mm

IMPRINT: W;904

QTY: 100 Tablets

Label

DRUG: Captopril

GENERIC: Captopril

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-905-02

STRENGTH: 100 mg

COLOR: White

SHAPE: Round

SCORE: Scored

SIZE: 11 mm

IMPRINT: W;905

QTY: 1000 Tablets

Label