Glyburide and Metformin Hydrochloride (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/500 mg (100 Tablets Bottle)

NDC: 51655-942-26

Label
(click image for full-size original)
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-942(NDC:65862-082)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 5 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
POVIDONE K90
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
PROPYLENE GLYCOL
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape CAPSULE (Biconvex) Size 17mm
Flavor Imprint Code A;48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-942-26 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077870 05/21/2020
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-942)

Revised: 12/2021 Northwind Pharmaceuticals

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