PredniSONE (Page 3 of 3)

HOW SUPPLIED

50 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” debossed on the other side.

NDC: 70518-0306-00

NDC: 70518-0306-01

PACKAGING: 5 in 1 BOTTLE PLASTIC

PACKAGING: 10 in 1 BOTTLE PLASTIC

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, child-resistant container as defined in the USP/NF.

PROTECT FROM MOISTURE.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: PredniSONE

GENERIC: PredniSONE

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0306-0

NDC: 70518-0306-1

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 10 mm

IMPRINT: 54;343

PACKAGING: 5 in 1 BOTTLE, PLASTIC

PACKAGING: 10 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • PREDNISONE 50mg in 1

INACTIVE INGREDIENT(S):

  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • STARCH, CORN
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
PREDNISONE
prednisone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0306(NDC:0054-0019)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISONE (PREDNISONE) PREDNISONE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 54;343
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0306-0 5 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:70518-0306-1 10 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084283 03/10/2017
Labeler — REMEDYREPACK INC. (829572556)

Revised: 01/2022 REMEDYREPACK INC.

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