NDC Code(s) : 52125-607-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-607(NDC:60505-0260)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLCELLULOSE (25 CPS)(UNII: BI55GG2WLI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color white Score no score
Shape CAPSULE (TABLET, EXTENDED RELEASE) Size 19 mm
Flavor Imprint Code APO;XR500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-607-0230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076706 04/16/2014

PRINCIPAL DISPLAY PANEL

DRUG: Metformin Hydrochloride


GENERIC: Metformin Hydrochloride


DOSAGE: TABLET, EXTENDED RELEASE


ADMINSTRATION: ORAL


NDC: 52125-607-02


ACTIVE INGREDIENT(S):

  • METFORMIN HYDROCHLORIDE 500mg in 1


INACTIVE INGREDIENT(S):

  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • METHYLCELLULOSE (25 CPS)
  • SILICON DIOXIDE


COLOR: white


SHAPE: CAPSULE


SCORE: No score


SIZE: 19 mm


IMPRINT: APO;XR500


PACKAGING: 30 in 1 BLISTER PACK




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