Label: GLIMEPIRIDE tablet
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NDC Code(s):
61919-250-04,
61919-250-30,
61919-250-60,
61919-250-82, view more61919-250-90
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 16729-003
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 10, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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
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INGREDIENTS AND APPEARANCE
GLIMEPIRIDE
glimepiride tabletProduct 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)
