GLIMEPIRIDE by DIRECT RX GLIMEPIRIDE tablet

GLIMEPIRIDE by

Drug Labeling and Warnings

GLIMEPIRIDE by is a Prescription medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLIMEPIRIDE 
glimepiride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-250(NDC:16729-003)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)	GLIMEPIRIDE	4 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	blue	Score	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	AHI;4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-250-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2016
2	NDC: 61919-250-04	4 in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2016
3	NDC: 61919-250-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2016
4	NDC: 61919-250-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2016
5	NDC: 61919-250-82	180 in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078181	02/04/2016

Labeler - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	repack(61919-250)