NDC Code(s) : 61786-271-60
Packager : REMEDYREPACK INC.

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:61786-271(NDC:23155-104)
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
BLACKBERRY(UNII: 8A6OMU3I8L)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POVIDONE K90(UNII: RDH86HJV5Z)
POVIDONE K30(UNII: U725QWY32X)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color white Score 2 pieces
Shape OVAL (TABLET) Size 19 mm
Flavor Imprint Code H;104
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-271-6060 in 1 BOTTLE Type 0: Not a Combination Product10/12/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090564 12/10/2015 06/14/2017

PRINCIPAL DISPLAY PANEL

DRUG: Metformin hydrochloride


GENERIC: Metformin hydrochloride


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 61786-271-60


ACTIVE INGREDIENT(S):

  • METFORMIN HYDROCHLORIDE 1000mg in 1


INACTIVE INGREDIENT(S):

  • BLACKBERRY
  • HYPROMELLOSE 2910 (5 MPA.S)
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 400
  • MALTODEXTRIN
  • HYPROMELLOSE 2910 (6 MPA.S)
  • POVIDONE K90
  • POVIDONE K30
  • STARCH, CORN


COLOR: white


SHAPE: OVAL


SCORE: Two even pieces


SIZE: 19 mm


IMPRINT: H;104


PACKAGING: 60 in 1 BOTTLE




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