Lisinopril (Page 8 of 8)

HOW SUPPLIED

Lisinopril Tablets, USP are available as:

2.5 mg tablet is a white to off-white, round, biconvex, uncoated, tablet with “LUPIN” debossed on one side and “2.5” on other side. They are available as follows:

Bottles of 90 NDC 68180-512-09

Bottles of 100 NDC 68180-512-01

Bottles of 500 NDC 68180-512-02

Bottles of 1000 NDC 68180-512-03

5 mg tablet is a pink coloured, round, biconvex, uncoated, tablet with “5” debossed on one side and breakline on other side. They are available as follows:

Bottles of 90 NDC 68180-513-09

Bottles of 100 NDC 68180-513-01

Bottles of 500 NDC 68180-513-02

Bottles of 1000 NDC 68180-513-03

Bottles of 5000 NDC 68180-513-05

10 mg tablet is a pink coloured, round, biconvex, uncoated, tablet with “LUPIN” debossed on one side and “10” on other side. They are available as follows:

Bottles of 90 NDC 68180-514-09

Bottles of 100 NDC 68180-514-01

Bottles of 500 NDC 68180-514-02

Bottles of 1000 NDC 68180-514-03

Bottles of 5000 NDC 68180-514-05

20 mg tablet is a pink coloured, round, biconvex, uncoated, tablet with “LUPIN” debossed on one side and “20” on other side. They are available as follows:

Bottles of 90 NDC 68180-515-09

Bottles of 100 NDC 68180-515-01

Bottles of 500 NDC 68180-515-02

Bottles of 1000 NDC 68180-515-03

Bottles of 5000 NDC 68180-515-05

30 mg tablet is a red coloured, round, biconvex, uncoated, tablet with “LUPIN” debossed on one side and “30” on other side. They are available as follows:

Bottles of 90 NDC 68180-516-09

Bottles of 100 NDC 68180-516-01

Bottles of 500 NDC 68180-516-02

Bottles of 1000 NDC 68180-516-03

40 mg tablet is a yellow coloured, round, biconvex, uncoated, tablet with “LUPIN” debossed on one side and “40” on other side. They are available as follows:

Bottles of 90 NDC 68180-517-09

Bottles of 100 NDC 68180-517-01

Bottles of 500 NDC 68180-517-02

Bottles of 1000 NDC 68180-517-03

Bottles of 2000 NDC 68180-517-04

Storage:

Store at 20º to 25ºC (68º to 77ºF)[see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States.

Manufactured by:

Lupin Limited

Goa 403 722

INDIA.

Or

Lupin Limited

Pithampur (M.P.) 454 775

INDIA.

Revised: July 5, 2013 ID#: 233363

PRINCIPAL DISPLAY PANEL

Lisinopril5mg
(click image for full-size original)

LISINOPRIL lisinopril tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33358-211(NDC:68180-512)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MANNITOL
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code LUPIN;2;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33358-211-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077321 11/18/2014
Labeler — RxChange Co. (781126805)
Establishment
Name Address ID/FEI Operations
RxChange Co. 781126805 repack (33358-211)

Revised: 11/2014 RxChange Co.

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