GLYBURIDE by DirectRX GLYBURIDE tablet

GLYBURIDE by

Drug Labeling and Warnings

GLYBURIDE by is a Prescription medication manufactured, distributed, or labeled by DirectRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

Package Label

INGREDIENTS AND APPEARANCE

GLYBURIDE 
glyburide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-378(NDC:23155-058)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)	GLYBURIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score	2 pieces
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	I37
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-378-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/03/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090937	12/03/2015

Labeler - DirectRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRX		079254320	repack(61919-378)