NDC Code(s) : 68180-150-01
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FamotidineFamotidine POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE40 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
METHYLPARABEN SODIUM(UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM(UNII: 625NNB0G9N)
SODIUM BENZOATE(UNII: OJ245FE5EU)
Product Characteristics
Color WHITE Score
Shape Size
Flavor CHERRY, BANANA, PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-150-0150 mL in 1 BOTTLE Type 0: Not a Combination Product29/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090440 06/29/2010

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 677600414 MANUFACTURE(68180-150), PACK(68180-150)

PRINCIPAL DISPLAY PANEL

container label

NDC 68180-150-01

Famotidine for Oral Suspension USP

40 mg/5 mL

50 mL (when reconstituted)