Label: GLYBURIDE tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 61919-378-60 - Packager: DirectRX
- This is a repackaged label.
- Source NDC Code(s): 23155-058
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 4, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Description
- Clinical Pharmacology
- Indications and Usage
- Contraindications
- Precautions
- Adverse Reactions
- Overdosage
- Dosage and Administration
- Package Label
-
INGREDIENTS AND APPEARANCE
GLYBURIDE
glyburide tabletProduct 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)
