NDC Code(s) : 72336-064-30
Packager : LifSa Drugs, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin HydrochlorideMetformin Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72336-064
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE625 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
COPOVIDONE K25-31(UNII: D9C330MD8B)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CROSPOVIDONE(UNII: 2S7830E561)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color white Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code CE;64
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72336-064-3030 in 1 BOTTLE Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075972 01/24/2002

LABELER - LifSa Drugs, LLC(081205160)

REGISTRANT - Chartwell Pharmaceuticals Congers, LLC(118673447)

Establishment
Name Address ID/FEI Business Operations
Chartwell Pharmaceuticals Congers, LLC 118673447 analysis(72336-064), label(72336-064), manufacture(72336-064), pack(72336-064)

PRINCIPAL DISPLAY PANEL

Metformin Hydrochloride Tablets-625mg-NDC 72336-064-30- 30s Label

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