CAPTOPRIL (Page 6 of 6)

HOW SUPPLIED

Captopril Tablets USP

12.5 mg tablets in bottles of 100 (NDC 64679-902-01) and 1000 (NDC 64679-902-02),

25 mg tablets in bottles of 100 (NDC 64679-903-01) and 1000 (NDC 64679-903-02),

50 mg tablets in bottles of 100 (NDC 64679-904-01) and 1000 (NDC 64679-904- 02), and

100 mg tablets in bottles of 100 (NDC 64679-905-01)

Bottle contains desiccant.

The 12.5 mg tablet is white, flat bevelled-edge round with a bisect bar on one side and ‘W’ on the other side; the 25 mg Captopril tablet is a white, flat bevelled-edge round with

902

a quadrisect bar on one side and ‘W’ on the other side; the 50 mg Captopril tablet is a

903

white, flat bevelled-edge round with a bisect bar on one side and ‘W’ on the other side;

904

the 100 mg Captopril tablet is a white, flat bevelled-edge round with a bisect bar on one side and ‘W’ on the other side.

905

All captopril tablets are white and may exhibit a slight sulfurous odor.

Dispense in a tight container as defined in the USP.

Storage

Do not store above 30°C (86°F) Keep bottles tightly closed (protect from moisture).

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Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.260614

Principal Display Panel

Captopril Tablets, USP 50mg
30 Tablets
NDC 10544-175-30

50mg 30ct
(click image for full-size original)

CAPTOPRIL
captopril tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-175(NDC:64679-904)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPTOPRIL (CAPTOPRIL) CAPTOPRIL 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
PALMITIC ACID
SILICON DIOXIDE
STARCH, CORN
TALC
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (flat bevelled-edge) Size 8mm
Flavor Imprint Code W;904
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-175-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074532 11/15/2013
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-175)

Revised: 10/2015 Blenheim Pharmacal, Inc.

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