NDC Code(s) : 43063-527-14, 43063-527-20, 43063-527-30, 43063-527-60, 43063-527-90, 43063-527-98, 43063-527-93, 43063-527-94
Packager : PD-Rx Pharmaceuticals, 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:43063-527(NDC:53746-218)
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
ACACIA(UNII: 5C5403N26O)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code IP218;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-527-1414 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/12/2017
2NDC:43063-527-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/09/2013
3NDC:43063-527-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/09/2013
4NDC:43063-527-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/09/2013
5NDC:43063-527-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/09/2013
6NDC:43063-527-98120 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/09/2013
7NDC:43063-527-93180 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/09/2013
8NDC:43063-527-94270 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077880 12/17/2012

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-527)

PRINCIPAL DISPLAY PANEL

Metformin Hydrochloride Tablets USP, 500 mg

Rx only

43063527 Label