NDC Code(s) : 61786-299-23
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:61786-299(NDC:23155-103)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE850 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30(UNII: U725QWY32X)
POVIDONE K90(UNII: RDH86HJV5Z)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
BLACKBERRY(UNII: 8A6OMU3I8L)
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (biconvex) Size 13 mm
Flavor Imprint Code H;103
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-299-23180 in 1 BOTTLE Type 0: Not a Combination Product29/10/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090564 10/29/2015 03/28/2017

PRINCIPAL DISPLAY PANEL

DRUG: Metformin hydrochloride

GENERIC: Metformin hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-299-23

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: H;103

PACKAGING: 180 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • METFORMIN HYDROCHLORIDE 850mg 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

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