NDC Code(s) : 55150-237-01, 55150-238-05, 55150-239-30
Packager : Eugia US LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:55150-237
Route of Administration INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, 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
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM SULFITE(UNII: VTK01UQK3G)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55150-237-0125 in 1 CARTON 12/01/2015
11 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206781 12/01/2015
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:55150-238
Route of Administration INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, 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
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM SULFITE(UNII: VTK01UQK3G)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55150-238-0525 in 1 CARTON 12/01/2015
15 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206781 12/01/2015
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:55150-239
Route of Administration INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, INTRALESIONAL, 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
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM SULFITE(UNII: VTK01UQK3G)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55150-239-3025 in 1 CARTON 12/01/2015
130 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206781 12/01/2015

LABELER - Eugia US LLC(968961354)

Establishment
Name Address ID/FEI Business Operations
Eugia Pharma Specialities Limited 650498244 ANALYSIS(55150-237, 55150-238, 55150-239), MANUFACTURE(55150-237, 55150-238, 55150-239), PACK(55150-237, 55150-238, 55150-239)

PRINCIPAL DISPLAY PANEL

                             NDC 55150-237-01
Dexamethasone
Sodium Phosphate
Injection USP
4 mg per mL
For I.V. or I.M. Use#
1 mL                       Single-Dose Vial
Rx only


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg per mL Container Label

PRINCIPAL DISPLAY PANEL

                       NDC 55150-237-01
Dexamethasone
Sodium Phosphate
Injection USP
4 mg per mL*
For Intravenous, Intramuscular, Intra-Articular,
Soft Tissue or Intralesional Use
Sterile                 25 x 1 mL
                          Single-Dose Vials
Rx only
eugia
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg per mL Container-Carton (25 Vials)

PRINCIPAL DISPLAY PANEL

                          NDC 55150-238-05
Dexamethasone
Sodium Phosphate
Injection USP
20 mg per 5 mL
(4 mg/mL)*
For I.V. or I.M. Use#
5 mL           Multiple-Dose Vial
Rx only


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 5 mL (4 mg / mL) Container Label

PRINCIPAL DISPLAY PANEL

                  NDC 55150-238-05
Dexamethasone
Sodium Phosphate
Injection USP
20 mg per 5 mL
(4 mg/mL)*
For Intravenous, Intramuscular, Intra-Articular,
Soft Tissue or Intralesional Use
Sterile             25 x 5 mL
                      Multiple-Dose Vials
Rx only
eugia


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 5 mL (4 mg / mL) Container-Carton (25 Vials)

PRINCIPAL DISPLAY PANEL

                       NDC 55150-239-30
Dexamethasone
Sodium Phosphate
Injection USP
120 mg per 30 mL
 (4 mg/mL)*
For I.V., I.M., Intra-Articular,
Soft Tissue or Intralesional Use
30 mL             Multiple-Dose Vial
Rx only


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg per 30 mL (4 mg / mL) Container Label

PRINCIPAL DISPLAY PANEL

                        NDC 55150-239-30
Dexamethasone
Sodium Phosphate
Injection USP
120 mg per 30 mL
 (4 mg/mL)*
For Intravenous, Intramuscular, Intra-Articular,
Soft Tissue or Intralesional Use
Sterile                      25 x 30 mL
                      Multiple-Dose Vials
Rx only
eugia
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg per 30 mL (4 mg / mL) Container-Carton (25 Vials)