NDC Code(s) : 52125-957-03
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PrednisonePrednisone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-957(NDC:0143-9739)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISONE(UNII: VB0R961HZT)
(PREDNISONE - UNII:VB0R961HZT) 		PREDNISONE10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score 2 pieces
Shape ROUND (TABLET) Size 9 mm
Flavor Imprint Code Westward;473
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-957-0320 in 1 BOTTLE Type 0: Not a Combination Product14/09/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088832 09/04/2014 04/25/2016

PRINCIPAL DISPLAY PANEL

DRUG: Prednisone


GENERIC: Prednisone


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 52125-957-03


ACTIVE INGREDIENT(S):

  • PREDNISONE 10mg in 1


INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • CELLULOSE, MICROCRYSTALLINE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • MAGNESIUM STEARATE
  • SILICON DIOXIDE
  • TALC


COLOR: white


SHAPE: ROUND


SCORE: Two even pieces


SIZE: 9 mm


IMPRINT: Westward;473


PACKAGING: 20 in 1 BOTTLE




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