NDC Code(s) : 45802-303-21, 45802-303-67
Packager : Perrigo New York 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:45802-303
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)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code WestWard;473
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-303-211 in 1 CARTON 29/06/2006
121 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:45802-303-672 in 1 CARTON 19/05/2006
224 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088832 05/19/2006 06/01/2014

PRINCIPAL DISPLAY PANEL

Rx Only

PredniSONE Tablets, USP 10 mg

EACH TABLET CONTAINS: Prednisone USP, 10 mg

USUAL DOSAGE: See package insert.

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

Protect from light and moisture.

Keep patient under close observation of a physician.

For your family's protection, this package has been tested for child resistance.

Unit of Use

PredniSONE Tablets, USP Carton Image 1PredniSONE Tablets, USP Carton Image 1