GLYBURIDE- glyburide tablet
DirectRX
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GLYBURIDE
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Precautions
Adverse Reactions
Overdosage
Dosage and Administration
Package Label
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)
Revised: 12/2015
Document Id:
2615ee96-7a3e-5cde-e054-00144ff8d46c
Set id: 2615ee96-7a3d-5cde-e054-00144ff8d46c
Version: 1
Effective Time: 20151204
DirectRX