NDC Code(s) : 52125-971-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

glipizideglipizide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-971(NDC:57664-398)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE(UNII: X7WDT95N5C)
(GLIPIZIDE - UNII:X7WDT95N5C) 		GLIPIZIDE5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
STARCH, POTATO(UNII: 8I089SAH3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape ROUND (TABLET) Size 8 mm
Flavor Imprint Code 398
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-971-0230 in 1 BLISTER PACK Type 0: Not a Combination Product09/09/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077820 09/09/2014 03/12/2016

PRINCIPAL DISPLAY PANEL

DRUG: glipizide


GENERIC: glipizide


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 52125-971-02


ACTIVE INGREDIENT(S):

  • Glipizide 5mg in 1


INACTIVE INGREDIENT(S):

  • cellulose, microcrystalline
  • lactose monohydrate
  • silicon dioxide
  • starch, corn
  • starch, potato
  • stearic acid


COLOR: white


SHAPE: ROUND


SCORE: Two even pieces


SIZE: 8 mm


IMPRINT: 398


PACKAGING: 30 in 1 BLISTER PACK




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