Methylprednisolone Sodium Succinate (Page 6 of 6)

Methylprednisolone Sodium Succinate for Injection, USP 125 mg* per vial-Vial Label

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Methylprednisolone Sodium Succinate for Injection, USP 500

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Methylprednisolone Sodium Succinate for Injection, USP 1g* per vial-Vial Label

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Methylprednisolone Sodium Succinate for Injection, USP 40 mg* per vial — carton label

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Methylprednisolone Sodium Succinate for Injection, USP 125 mg* per vial — carton label

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Methylprednisolone Sodium Succinate for Injection, USP 500 mg* per vial — carton label

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Methylprednisolone Sodium Succinate for Injection, USP 500 mg* per vial — carton label

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METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-127
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.84 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 17.46 mg in 1 mL
LACTOSE MONOHYDRATE 25 mg in 1 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-127-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (43598-127-45)
1 NDC:43598-127-45 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (43598-127-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212396 03/24/2022
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-129
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 125 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.84 mg in 2 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 17.4 mg in 2 mL
Product Characteristics
Color WHITE (white to offi-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-129-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (43598-129-01)
1 NDC:43598-129-01 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (43598-129-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212396 03/24/2022
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-128
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 500 mg in 8 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 7.36 mg in 8 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 69.6 mg in 8 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-128-11 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 8 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (43598-128-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212396 03/24/2022
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-130
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 1 g in 16 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 14.72 mL in 16 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 139.2 mg in 16 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-130-74 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 16 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (43598-130-74)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212396 03/24/2022
Labeler — Dr. Reddy’s Laboratories Inc (802315887)
Registrant — Tianjin Kingyork Pharmaceuticals Co., Ltd (544518503)
Establishment
Name Address ID/FEI Operations
Tianjin Kingyork Pharmaceuticals Co., Ltd 544518503 analysis (43598-127), analysis (43598-128), analysis (43598-129), analysis (43598-130), manufacture (43598-127), manufacture (43598-128), manufacture (43598-129), manufacture (43598-130)

Revised: 05/2022 Dr. Reddy’s Laboratories Inc

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