NDC Code(s) : 0009-0039-33, 0009-0039-32, 0009-0047-27, 0009-0047-26
Packager : Pharmacia and Upjohn Company LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Solu-Medrolmethylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0039
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE(UNII: LEC9GKY20K)
(METHYLPREDNISOLONE - UNII:X4W7ZR7023) 		METHYLPREDNISOLONE40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)1.6 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)17.46 mg in 1 mL
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)25 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-0039-3225 in 1 CARTON 02/04/1959
1NDC:0009-0039-331 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011856 04/02/1959
Solu-Medrolmethylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0047
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE(UNII: LEC9GKY20K)
(METHYLPREDNISOLONE - UNII:X4W7ZR7023) 		METHYLPREDNISOLONE125 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)1.6 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)17.4 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0009-0047-2625 in 1 CARTON 02/04/1959
1NDC:0009-0047-272 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011856 04/02/1959

PRINCIPAL DISPLAY PANEL

NDC 0009-0039-33

Rx ONLY

SOLU-MEDROL®
Methylprednisolone Sodium
Succinate for Injection, USP
Single-Use Vial

For IM or IV Use Only

Discard unused
portion.

40 mg* per vial

Preservative-Free
1 mL Act-O-Vial®
System

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 1 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0009-0039-32
Contains 25 of NDC 0009-0039-33

SOLU-MEDROL®
Methylprednisolone Sodium
Succinate for Injection, USP

40 mg* per vial

Preservative-Free

25–1 mL Act-O-Vial®
Systems

For Intramuscular or Intravenous Use Only

Single-Use Vials

Discard unused portion.

Rx ONLY

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0009-0047-27

Rx ONLY

SOLU-MEDROL®
Methylprednisolone Sodium
Succinate for Injection, USP
Single-Use Vial

For IM or IV Use Only

Discard unused
portion.

125 mg* per vial

Preservative-Free
2 mL Act-O-Vial®
System

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0009-0047-26
Contains 25 of NDC 0009-0047-27

SOLU-MEDROL®
Methylprednisolone Sodium
Succinate for Injection, USP

125 mg* per vial

Preservative-Free

25–2 mL Act-O-Vial®
Systems

For Intramuscular or Intravenous Use Only

Single-Use Vials

Discard unused portion.

Rx ONLY

NOVAPLUS®

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton