NDC Code(s) : 0641-0367-21, 0641-0367-25, 0641-6145-01, 0641-6145-25, 0641-6146-01, 0641-6146-10, 0641-6146-25
Packager : Hikma Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-0367
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-0367-2525 in 1 CARTON 09/07/1982
1NDC:0641-0367-211 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
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-6145-2525 in 1 CARTON 15/07/1975
1NDC:0641-6145-011 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
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-6146-1010 in 1 CARTON 10/03/2023
1NDC:0641-6146-015 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:0641-6146-2525 in 1 CARTON 15/07/1975
2NDC:0641-6146-015 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
ANDA ANDA084282 07/15/1975

LABELER - Hikma Pharmaceuticals USA Inc.(946499746)

PRINCIPAL DISPLAY PANEL

NDC 0641-0367-21      Rx only
Dexamethasone
Sodium Phosphate
Injection, USP
10 mg/mL
(dexamethasone phosphate equivalent)
For IV or IM use ONLY
Protect from light
1 mL Vial

10 mg-mL vial

NDC 0641-0367-25       Rx only
Dexamethasone
Sodium Phosphate Injection, USP
10 mg/mL
(dexamethasone phosphate equivalent)
For Intravenous or
Intramuscular use ONLY
25 x 1 mL Vials

10 mg-mL vial

PRINCIPAL DISPLAY PANEL

NDC 0641-6145-01   Rx only
Dexamethasone
Sodium Phosphate
Injection, USP
4 mg/mL       
(dexamethasone phosphate equivalent)
For IV, IM, Intralesional,
Intra-articular or
 Soft Tissue use
 Protect from light
1 mL Vial

  unit label

NDC 0641-6145-25  Rx only
Dexamethasone
Sodium Phosphate Injection, USP
4 mg/mL       
(dexamethasone phosphate equivalent)
For Intravenous, Intramuscular,
Intralesional, Intra-articular or
Soft Tissue use
25 x 1 mL Vials

unit label

PRINCIPAL DISPLAY PANEL

NDC 0641-6146-01    Rx only
Dexamethasone
Sodium Phosphate Injection, USP
20 mg per 5 mL (4 mg/mL)      
(dexamethasone phosphate equivalent)
For IV, IM, Intralesional,
Intra-articular or Soft Tissue use
5 mL Vial

unit label

NDC 0641-6146-10    Rx only
Dexamethasone
Sodium Phosphate Injection, USP
20 mg per 5 mL
(4 mg/mL)      
(dexamethasone phosphate equivalent)
For Intravenous, Intramuscular,
Intralesional, Intra-articular or
Soft Tissue use
10 x 5 mL Vials

unit label

PRINCIPAL DISPLAY PANEL

serialization image