PredniSONE (Page 3 of 3)

HOW SUPPLIED

PredniSONE Tablets, USP

5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side.

NDC 68071-2578-1 BOTTLES OF 100

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

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

Distr. by: Hikma

Pharmaceuticals USA Inc.

Eatontown, NJ 07724

C50000278/03

Revised December 2020

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

pdp
(click image for full-size original)

PREDNISONE
prednisone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2578(NDC:0054-4728)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISONE (PREDNISONE) PREDNISONE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 54;612
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2578-1 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080352 04/21/1972
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-2578)

Revised: 11/2021 NuCare Pharmaceuticals,Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.