NDC Code(s) : 0009-3073-01, 0009-3073-03, 0009-3475-01, 0009-3475-03
Packager : Pharmacia & Upjohn Company LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Depo-Medrolmethylprednisolone acetate INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-3073
Route of Administration INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE ACETATE(UNII: 43502P7F0P)
(METHYLPREDNISOLONE - UNII:X4W7ZR7023) 		METHYLPREDNISOLONE ACETATE40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)29 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-3073-011 in 1 PACKAGE 28/05/1959
11 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0009-3073-0325 in 1 PACKAGE 28/05/1959
21 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011757 05/28/1959
Depo-Medrolmethylprednisolone acetate INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-3475
Route of Administration INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE ACETATE(UNII: 43502P7F0P)
(METHYLPREDNISOLONE - UNII:X4W7ZR7023) 		METHYLPREDNISOLONE ACETATE80 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)28 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-3475-011 in 1 PACKAGE 28/05/1959
11 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0009-3475-0325 in 1 PACKAGE 28/05/1959
21 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011757 05/28/1959

LABELER - Pharmacia & Upjohn Company LLC(618054084)

Establishment
Name Address ID/FEI Business Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS(0009-3073, 0009-3475), MANUFACTURE(0009-3073, 0009-3475), API MANUFACTURE(0009-3073, 0009-3475), PACK(0009-3073, 0009-3475), LABEL(0009-3073, 0009-3475)

PRINCIPAL DISPLAY PANEL

NDC 0009-3073-01

1 mL Single-Dose Vial
Depo-Medrol ®

(methylPREDNISolone
acetate injectable
suspension, USP)

40 mg/mL

Rx only

PRINCIPAL DISPLAY PANEL - 40 mg/mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0009-3073-03
Contains 25 of NDC 0009-3073-01

25—1 mL Single-Dose Vials
Depo-Medrol ®

(methylPREDNISolone acetate
injectable suspension, USP)

40 mg/mL

For intramuscular, intrasynovial and soft tissue injection only
NOT for IV use

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 40 mg/mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0009-3475-01

1 mL Single-Dose Vial
Depo-Medrol ®

(methylPREDNISolone
acetate injectable
suspension, USP)

80 mg/mL

Rx only

PRINCIPAL DISPLAY PANEL - 80 mg/mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0009-3475-03
Contains 25 of NDC 0009-3475-01

25—1 mL Single-Dose Vials
Depo-Medrol ®

(methylPREDNISolone acetate
injectable suspension, USP)

80 mg/mL

For intramuscular, intrasynovial and soft tissue injection only
NOT for IV use

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 80 mg/mL Vial Carton