NDC Code(s) : 61786-538-02, 61786-538-58, 61786-538-55
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:61786-538(NDC:59746-173)
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
STARCH, POTATO(UNII: 8I089SAH3T)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code TL173
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-538-0230 in 1 BLISTER PACK Type 0: Not a Combination Product25/01/2016
2NDC:61786-538-5848 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2016
3NDC:61786-538-5542 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product13/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040362 01/25/2016

PRINCIPAL DISPLAY PANEL

DRUG: Prednisone

GENERIC: Prednisone

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-538-02

NDC: 61786-538-58

NDC: 61786-538-55

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 9 mm

IMPRINT: TL173

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 48 in 1 BOTTLE PLASTIC

PACKAGING: 42 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • Prednisone 10mg in 1

INACTIVE INGREDIENT(S):

  • Lactose monohydrate
  • Starch, Corn
  • Sodium lauryl sulfate
  • Magnesium stearate
  • Starch, Potato

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/xml/05d28cd3-e853-42f1-9496-b439d1b6fcd7/Remedy_Label.jpg

/xml/05d28cd3-e853-42f1-9496-b439d1b6fcd7/Remedy_Label.jpg