NDC Code(s) : 0069-4547-01, 0069-4547-02, 0069-4543-01, 0069-4543-02, 0069-4545-01, 0069-4545-02, 0069-4541-01, 0069-4541-02
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4547
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
METHYLPARABEN(UNII: A2I8C7HI9T)1.5 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.2 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.11 mg in 1 mL
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)10 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4547-0225 in 1 CARTON 11/05/2011
1NDC:0069-4547-011 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 ANDA040803 05/11/2011
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4543
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
METHYLPARABEN(UNII: A2I8C7HI9T)1.5 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.2 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.11 mg in 1 mL
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)10 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4543-0225 in 1 CARTON 11/05/2011
1NDC:0069-4543-015 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 ANDA040803 05/11/2011
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4545
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
METHYLPARABEN(UNII: A2I8C7HI9T)1.5 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.2 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.11 mg in 1 mL
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)10 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4545-0225 in 1 CARTON 11/05/2011
1NDC:0069-4545-0130 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 ANDA040803 05/11/2011
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4541
Route of Administration INTRAVENOUS, INTRAMUSCULAR 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
METHYLPARABEN(UNII: A2I8C7HI9T)1.5 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.2 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.11 mg in 1 mL
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)10 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4541-0210 in 1 CARTON 11/05/2011
1NDC:0069-4541-0110 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 ANDA040802 05/11/2011

PRINCIPAL DISPLAY PANEL

NDC 0069-4547-01

1 mL Single-dose Vial

Dexamethasone Sodium
Phosphate Injection, USP
4 mg/mL*

Sterile
Rx only

For IV, IM, Intra-articular,
Soft tissue or Intralesional use

Principal Display Panel - 4 mg/mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-4547-02
Contains 25 of NDC 0069-4547-01
Rx only

25 x 1 mL Single-dose Vials

Dexamethasone Sodium
Phosphate Injection, USP
4 mg/mL*

Sterile

For IV, IM, Intra-articular, Soft tissue or Intralesional use

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 4 mg/mL Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-4543-01

5 mL Multi-dose Vial

Dexamethasone Sodium
Phosphate Injection, USP
20 mg/5 mL
(4 mg/mL*)

Sterile

For IV, IM, Intra-articular, Soft
tissue or Intralesional use
Rx only

Principal Display Panel - 20 mg/5 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-4543-02
Contains 25 of NDC 0069-4543-01
25 x 5 mL Multi-dose Vials
Rx only

Dexamethasone Sodium
Phosphate Injection, USP

20 mg/5 mL
(4 mg/mL*)

Sterile

For IV, IM, Intra-articular, Soft tissue or Intralesional use

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 20 mg/5 mL Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-4545-01

30 mL Multi-dose Vial

Dexamethasone Sodium
Phosphate Injection, USP
120 mg/30 mL
(4 mg/mL*)

Sterile

For IV, IM, Intra-articular,
Soft tissue or Intralesional use
Rx only

Principal Display Panel - 120 mg/30 mL Vial Label

PRINCIPAL DISPLAY PANEL

25 x 30 mL Multi-dose Vials

NDC 0069-4545-02
Contains 25 of NDC 0069-4545-01
Rx only

Dexamethasone Sodium
Phosphate Injection, USP

120 mg/30 mL
(4 mg/mL*)

Sterile

For IV, IM, Intra-articular, Soft tissue or Intralesional use

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 120 mg/30 mL Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-4541-01

10 mL Multi-dose Vial

Dexamethasone Sodium
Phosphate Injection, USP
100 mg/10 mL
(10 mg/mL)*

Sterile

For IM or IV use only
Rx only

Principal Display Panel - 100 mg/10 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-4541-02
Contains 10 of NDC 0069-4541-01
Rx only

10 x 10 mL Multi-dose Vials

Dexamethasone Sodium
Phosphate Injection, USP
100 mg/10 mL
(10 mg/mL*)

Sterile

For IM or IV use only

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 100 mg/10 mL Carton