NDC Code(s) : 0069-0179-01, 0069-0179-02, 0069-0178-01, 0069-0178-02, 0069-0192-01, 0069-0192-02, 0069-0177-01, 0069-0177-02
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:0069-0179
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:0069-0179-0225 in 1 CARTON
1NDC:0069-0179-011 mL in 1 VIAL
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:0069-0178
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:0069-0178-0225 in 1 CARTON
1NDC:0069-0178-015 mL in 1 VIAL
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:0069-0192
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:0069-0192-0225 in 1 CARTON
1NDC:0069-0192-0130 mL in 1 VIAL
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:0069-0177
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:0069-0177-0210 in 1 CARTON
1NDC:0069-0177-0110 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040802 05/11/2011

PRINCIPAL DISPLAY PANEL

NDC 0069-0179-01
Rx ONLY

Dexamethasone Sodium
Phosphate Injection, USP

1 mL Single-dose Vial
Sterile

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

NOVAPLUS ®

4 mg/
mL*

PRINCIPAL DISPLAY PANEL - 4 mg/mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0179-02
Contains 25 of NDC 0069-0179-01

Rx ONLY

Dexamethasone Sodium Phosphate
Injection, USP

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

25 x 1 mL Single-dose Vials
Sterile

NOVAPLUS ®

4 mg/mL*

PRINCIPAL DISPLAY PANEL - 4 mg/mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-0178-01
Rx ONLY

Dexamethasone Sodium
Phosphate Injection, USP

5 mL Multi-dose Vial
Sterile

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

Distributed by Pfizer Labs
Division of Pfizer Inc
New York, NY 10017

NOVAPLUS ®

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

PRINCIPAL DISPLAY PANEL - 20 mg/5 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0178-02
Contains 25 of NDC 0069-0178-01

Rx ONLY

Dexamethasone Sodium Phosphate
Injection, USP

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

25 x 5 mL Multi-dose Vials
Sterile

NOVAPLUS ®

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

PRINCIPAL DISPLAY PANEL - 20 mg/5 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-0192-01
Rx ONLY

Dexamethasone Sodium
Phosphate Injection, USP

30 mL Multi-dose Vial
Sterile

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

Distributed by Pfizer Labs
Division of Pfizer Inc
New York, NY 10017

NOVAPLUS ®

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

PRINCIPAL DISPLAY PANEL - 120 mg/30 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0192-02
Contains 25 of NDC 0069-0192-01

Rx ONLY

Dexamethasone Sodium Phosphate
Injection, USP

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

25 x 30 mL Multi-dose Vials
Sterile

NOVAPLUS ®

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

PRINCIPAL DISPLAY PANEL - 120 mg/30 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-0177-01
Rx ONLY

Dexamethasone Sodium
Phosphate Injection, USP

10 mL Multi-dose Vial
Sterile

For IM or IV use only

Distributed by Pfizer Labs
Division of Pfizer Inc
New York, NY 10017

NOVAPLUS ®

100 mg/
10 mL
(10 mg/mL*)

PRINCIPAL DISPLAY PANEL - 100 mg/10 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0177-02
Contains 10 of NDC 0069-0177-01

Rx ONLY

Dexamethasone Sodium Phosphate
Injection, USP

For IM or IV use only

10 x 10 mL Multi-dose Vials
Sterile

NOVAPLUS ®

100 mg/
10 mL
(10 mg/mL*)

PRINCIPAL DISPLAY PANEL - 100 mg/10 mL Vial Carton