Methylprednisolone Acetate (Page 6 of 6)

HOW SUPPLIED

Methylprednisolone acetate injectable suspension USP is available as single-dose vials in the following strengths and package sizes:

40 mg per mL
1 mL vials NDC 0703-0031 -01

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

Rx only

Rev. A 11/2011

Teva Pharmaceuticals USA

Sellersville, PA 18960

Distributed and additional labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PRINCIPAL DISPLAY PANEL

Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL Carton
(click image for full-size original)

Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL Carton Text

NDC 54868-0590-0 Rx only

MethylPREDNISolone
ACETATE Injectable
Suspension, USP

40 mg/mL

For IM, Intrasynovial and
Soft Tissue Injection Only.

NOT for IV use.

Sterile

1 mL Single Dose Vial


METHYLPREDNISOLONE ACETATE
methylprednisolone acetate injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0590(NDC:0703-0031)
Route of Administration INTRAMUSCULAR, INTRASYNOVIAL, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE ACETATE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350 29 mg in 1 mL
MYRISTYL-.GAMMA.-PICOLINIUM CHLORIDE 0.195 mg in 1 mL
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0590-0 1 VIAL, GLASS (VIAL) in 1 CARTON contains a VIAL, GLASS
1 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (54868-0590-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040557 07/26/2012
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-0590)

Revised: 08/2012 Physicians Total Care, Inc.

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