NDC Code(s) : 80005-119-16
Packager : Carnegie Pharmaceuticals LLC

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:80005-119
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
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
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 ((White to off White) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80005-119-1650 mL in 1 BOTTLE Type 0: Not a Combination Product08/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217137 08/10/2023

LABELER - Carnegie Pharmaceuticals LLC(079839141)

REGISTRANT - Carnegie Pharmaceuticals LLC(079839141)

Establishment
Name Address ID/FEI Business Operations
Carnegie Pharmaceuticals LLC 079839141 manufacture(80005-119), analysis(80005-119), pack(80005-119), label(80005-119)

PRINCIPAL DISPLAY PANEL

Packet Label:

containerlabel