NDC Code(s) : 63323-258-03, 63323-255-03
Packager : APP Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-258
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 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS(UNII: KH7I04HPUU)1.6 mg in 2 mL
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)17.4 mg in 2 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-258-0325 in 1 TRAY
12 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040583 11/30/2004
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-255
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(UNII: GR686LBA74)17.46 mg in 1 mL
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)25 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-255-0325 in 1 TRAY
11 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040583 11/30/2004

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY - Methylprednisolone 1 mL Single Dose Vial Label

NDC 63323-255-03

275503

Methylprednisolone Sodium Succinate for Injection, USP

40 mg 

Reconstitute with 1 mL Bacteriostatic Water for Injection with Benzyl Alcohol.

Use within 48 hours after mixing.

For IV or IM Use

1 mL Single Dose Vial

Rx only

275503-vial 

 

 

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Methylprednisolone 1 mL Single Dose Vial Tray Label

NDC 63323-255-03

275503

Methylprednisolone Sodium Succinate for Injection, USP

40 mg* 

For IM or IV Use

Rx only

25 x 1 mL Single Dose Vials

 

275503-vial 

 

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Methylprednisolone 2 mL Single Dose Vial Label

NDC 63323-258-03

275803

Methylprednisolone Sodium Succinate for Injection, USP

125 mg 

Reconstitute with 2 mL Bacteriostatic Water for Injection with Benzyl Alcohol.

Use within 48 hours after mixing.

For IV or IM Use

2 mL Single Dose Vial

Rx only

275503-vial 


PACKAGE LABEL - PRINCIPAL DISPLAY - Methylprednisolone 2 mL Single Dose Vial Label

NDC 63323-258-03

275803

Methylprednisolone Sodium Succinate for Injection, USP

12 5 mg* 

For IM or IV Use

Rx only

25 x 2 mL Single Dose Vials

275503-vial