NDC Code(s) : 0517-4901-25, 0517-4905-25, 0517-4930-25
Packager : American Regent, 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:0517-4901
Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE PHOSPHATE(UNII: 2BP70L44PR)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE PHOSPHATE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE(UNII: VTK01UQK3G)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-4901-2525 in 1 TRAY
11 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087440 09/30/1990
Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-4905
Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE PHOSPHATE(UNII: 2BP70L44PR)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE PHOSPHATE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE(UNII: VTK01UQK3G)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-4905-2525 in 1 TRAY
15 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087440 09/30/1990
Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-4930
Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE PHOSPHATE(UNII: 2BP70L44PR)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE PHOSPHATE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE(UNII: VTK01UQK3G)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-4930-2525 in 1 BOX
130 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087440 09/30/1990

PRINCIPAL DISPLAY PANEL

NDC 0517-4901-25

DEXAMETHASONE
SODIUM PHOSPHATE
INJECTION, USP

4 mg/mL (Dexamethasone
Phosphate Equivalent)

1 mL SINGLE DOSE VIAL
FOR IV OR IM USE*

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL – 1 mL Label

PRINCIPAL DISPLAY PANEL

NDC 0517-4901-25

DEXAMETHASONE
SODIUM PHOSPHATE
INJECTION, USP

25 x 1 mL SINGLE DOSE VIALS
4 mg/mL (Dexamethasone Phosphate Equivalent)

Rx Only

FOR INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE
OR INTRALESIONAL USE
Each mL contains: Dexamethasone Sodium Phosphate 4.37 mg (equivalent to
4 mg of Dexamethasone Phosphate), Sodium Sulfite 1 mg, Benzyl Alcohol
10 mg, Water for Injection q.s.  Sodium Citrate for isotonicity. pH adjusted
with Citric Acid and/or Sodium Hydroxide. 
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to
86°F) (See USP Controlled Room Temperature). Sensitive to heat - Do not autoclave. 
Directions for Use: See Package Insert.    

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

Rev. 11/05

NDC 0517-4901-25 DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 25 x 1 mL SINGLE DOSE VIALS 4 mg/mL (Dexamethasone Phosphate Equivalent) Rx Only FOR INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE OR INTRALESIONAL USE Each mL contains: Dexamethasone Sodium Phosphate 4.37 mg (equivalent to 4 mg of Dexamethasone Phosphate), Sodium Sulfite 1 mg, Benzyl Alcohol 10 mg, Water for Injection q.s. Sodium Citrate for isotonicity. pH adjusted with Citric Acid and/or Sodium Hydroxide. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Sensitive to heat - Do not autoclave. Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05

PRINCIPAL DISPLAY PANEL

NDC 0517-4905-25

DEXAMETHASONE
SODIUM PHOSPHATE
INJECTION, USP

20 mg/5 mL (4mg/mL)
(Dexamethasone Phosphate Equivalent)

5 mL MULTIPLE DOSE VIAL
FOR IV OR IM USE*

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL – 5mL Label

PRINCIPAL DISPLAY PANEL

NDC 0517-4905-25

DEXAMETHASONE
SODIUM PHOSPHATE
INJECTION, USP

25 x 5 mL 
MULTIPLE DOSE VIALS
20 mg/5 mL  (4 mg/mL) (Dexamethasone Phosphate Equivalent)

Rx Only

FOR INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR,
SOFT TISSUE OR INTRALESIONAL USE
Each mL contains: Dexamethasone Sodium Phosphate 4.37 mg (equivalent to 4 mg of
Dexamethasone Phosphate), Sodium Sulfite 1 mg, Benzyl Alcohol 10 mg, Water for Injection q.s. 
Sodium Citrate for isotonicity. pH adjusted with Citric Acid and/or Sodium Hydroxide. 
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP
Controlled Room Temperature). Sensitive to heat - Do not autoclave. 
Directions for Use: See Package Insert.    

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

Rev. 5/09

PRINICPAL DISPLAY PANEL - 5 mL CARTON LABELING

PRINCIPAL DISPLAY PANEL

NDC 0517-4930-25

DEXAMETHASONE
SODIUM PHOSPHATE
INJECTION, USP

120 mg/30 mL (4 mg/mL)
(Dexamethasone Phosphate
Equivalent)

30 mL MULTIPLE DOSE VIAL
FOR IV, IM, INTRA-ARTICULAR,
SOFT TISSUE OR
INTRALESIONAL USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL – 30 mL Label