GLYBURIDE (Page 3 of 3)

HOW SUPPLIED

Glyburide tablets, USP are supplied as follows:

Glyburide tablets, USP 5 mg (Blue colored, slightly mottled, capsule shaped, biconvex tablets de-bossed with ‘I37 ‘ on one side and scored on the other side)

Bottles of 30 NDC 51655-492-52

Bottles of 60 NDC 51655-492-25

Bottles of 90 NDC 51655-492-26

Rx only

Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Dispensed in well closed containers with safety closures. Keep container tightly closed.

Manufactured by:

USV Private Limited

Daman — 396210, India

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

logo

Revised: 12/2019

Principal Display Panel

NDC: 51655-492-52

Label
(click image for full-size original)
GLYBURIDE
glyburide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-492(NDC:23155-058)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYBURIDE (GLYBURIDE) GLYBURIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE Size 9mm
Flavor Imprint Code I37
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-492-52 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:51655-492-25 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:51655-492-26 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090937 01/07/2021
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-492)

Revised: 01/2024 Northwind Pharmaceuticals, LLC

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