NDC Code(s) : 0009-0274-01, 0009-0280-02, 0009-0280-51, 0009-0280-03, 0009-0280-52, 0009-0306-02, 0009-0306-12
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:0009-0274
Route of Administration INTRAMUSCULAR, INTRASYNOVIAL, INTRALESIONAL, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE ACETATE(UNII: 43502P7F0P)
(METHYLPREDNISOLONE - UNII:X4W7ZR7023) 		METHYLPREDNISOLONE ACETATE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)29.5 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)1.97 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(UNII: 3980JIH2SW)6.9 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)1.44 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)9.3 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:0009-0274-011 in 1 CARTON 28/05/1959
15 mL in 1 VIAL, MULTI-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:0009-0280
Route of Administration INTRAMUSCULAR, INTRASYNOVIAL, 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)29.1 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)1.94 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(UNII: 3980JIH2SW)6.8 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)1.42 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)9.16 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:0009-0280-021 in 1 CARTON 28/05/1959
15 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
2NDC:0009-0280-5125 in 1 PACKAGE 28/05/1959
25 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
3NDC:0009-0280-0310 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product28/05/1959
4NDC:0009-0280-5225 in 1 PACKAGE 28/05/1959
410 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product28/05/1959
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:0009-0306
Route of Administration INTRAMUSCULAR, INTRASYNOVIAL, 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)28.2 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)1.88 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(UNII: 3980JIH2SW)6.59 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)1.37 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)8.88 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:0009-0306-025 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product28/05/1959
2NDC:0009-0306-1225 in 1 PACKAGE 28/05/1959
25 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product28/05/1959
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(0009-0274, 0009-0280, 0009-0306), MANUFACTURE(0009-0274, 0009-0280, 0009-0306), API MANUFACTURE(0009-0274, 0009-0280, 0009-0306), PACK(0009-0274, 0009-0280, 0009-0306), LABEL(0009-0274, 0009-0280, 0009-0306)

PRINCIPAL DISPLAY PANEL

5 mL Multidose Vial
NDC 0009-0274-01

Depo-Medrol®
(methylPREDNISolone acetate
injectable suspension, USP)

100 mg/5 mL

(20 mg/mL)
Rx only

PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Label

PRINCIPAL DISPLAY PANEL

5 mL
Multidose Vial

NDC 0009-0274-01

Depo-Medrol®
(methylPREDNISolone
acetate injectable
suspension, USP)

100 mg/5 mL

(20 mg/mL)

For intramuscular,
intrasynovial and
soft tissue injection only

NOT for IV use

Contains Benzyl Alcohol
as a Preservative

Rx only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Vial Carton

PRINCIPAL DISPLAY PANEL

5 mL Multidose Vial
NDC 0009-0280-02

Depo-Medrol®
(methylPREDNISolone acetate
injectable suspension, USP)

200 mg/5 mL
(40 mg/mL)

Rx only

PRINCIPAL DISPLAY PANEL - 200 mg/5 mL Vial Label

PRINCIPAL DISPLAY PANEL

25—5 mL Multidose Vials

NDC 0009-0280-51
Contains 25 of NDC 0009-0280-02

Depo-Medrol ®
(methylPREDNISolone acetate injectable suspension, USP)

200 mg/5 mL
(40 mg/mL)

For intramuscular, intrasynovial and soft tissue injection only
NOT for IV use
Contains Benzyl Alcohol as a Preservative

Pfizer Injectables

Rx only

PRINCIPAL DISPLAY PANEL - 200 mg/5 mL Vial Package

PRINCIPAL DISPLAY PANEL

5 mL Multidose Vial
NDC 0009-0306-02

Depo-Medrol®
(methylPREDNISolone acetate
injectable suspension, USP)

400 mg/5 mL
(80 mg/mL)

Rx only

PRINCIPAL DISPLAY PANEL - 400 mg/5 mL Vial Label

PRINCIPAL DISPLAY PANEL

5 mL
Multidose Vial

NDC 0009-0306-02

Depo-Medrol®
(methylPREDNISolone
acetate injectable
suspension, USP)

400 mg/5 mL
(80 mg/mL)

For intramuscular,
intrasynovial and
soft tissue injection only

NOT for IV use

Contains Benzyl Alcohol
as a Preservative

Rx only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 400 mg/5 mL Vial Carton