NDC Code(s) : 68788-8520-6
Packager : Preferred Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin HydrochlorideMetformin Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8520(NDC:68180-337)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
CROSPOVIDONE(UNII: 2S7830E561)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (OVAL) Size 21 mm
Flavor Imprint Code Q22;LU
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-8520-660 in 1 BOTTLE Type 0: Not a Combination Product09/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090692 09/01/2023

LABELER - Preferred Pharmaceuticals, Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals, Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL(68788-8520)

PRINCIPAL DISPLAY PANEL

Metformin Hydrochloride Extended-Release Tablets.

Rx only

1000 mg

NDC 68788-8520-6

60 Tablet Bottles

Metformin HCl Extended Release Tablets USP 1000mg