Glyburide and Metformin Hydrochloride (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg/500 mg

Rising® 68788-7180
Glyburide and
Metformin
Hydrochloride
Tablets, USP
2.5 mg/500 mg Rx only

Repackaged By: Preferred Pharmaceuticals Inc.

Glyburide and Metformin HCl Tablets, USP 2.5mg/500mg
(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:68788-7180(NDC:57237-024)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 2.5 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
FD&C RED NO. 40
Product Characteristics
Color PINK (Light Pink) Score no score
Shape CAPSULE (Biconvex) Size 17mm
Flavor Imprint Code A;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7180-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7180-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68788-7180-9 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68788-7180-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077870 07/16/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7180)

Revised: 07/2023 Preferred Pharmaceuticals Inc.

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