NDC Code 0641-0367-21 - Dexamethasone Sodium Phosphate

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate INJECTION

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM SULFITE(UNII: VTK01UQK3G)	1.5 mg in 1 mL
SODIUM CITRATE(UNII: 1Q73Q2JULR)	16.5 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)	10.42 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0641-0367-25	25 in 1 CARTON	09/07/1982
1	NDC:0641-0367-21	1 mL in 1 VIAL Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA087702	09/07/1982

Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate INJECTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0641-6145
Route of Administration	INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM SULFITE(UNII: VTK01UQK3G)	1 mg in 1 mL
SODIUM CITRATE(UNII: 1Q73Q2JULR)	19.4 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)	10.42 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0641-6145-25	25 in 1 CARTON	15/07/1975
1	NDC:0641-6145-01	1 mL in 1 VIAL Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA084282	07/15/1975

Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate INJECTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0641-6146
Route of Administration	INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM SULFITE(UNII: VTK01UQK3G)	1 mg in 1 mL
SODIUM CITRATE(UNII: 1Q73Q2JULR)	19.4 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)	10.42 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0641-6146-10	10 in 1 CARTON	10/03/2023
1	NDC:0641-6146-01	5 mL in 1 VIAL Type 0: Not a Combination Product
2	NDC:0641-6146-25	25 in 1 CARTON	15/07/1975
2	NDC:0641-6146-01	5 mL in 1 VIAL Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA084282	07/15/1975

LABELER - Hikma Pharmaceuticals USA Inc.(946499746)

NDC 0641-0367-21
API & Excipient Details