Dexamethasone Sodium Phosphate (Page 3 of 3)

HOW SUPPLIED

Dexamethasone sodium phosphate injection USP, 4 mg/mL is supplied as a clear, colorless solution, in single-dose and multiple-dose vials as follows:

4 mg/mL, 1 mL vial
1 mL, Single-Dose Vial: NDC 70121-1450-1
1 mL, 25 Single-Dose Vials in a Carton: NDC 70121-1450-5

4 mg/mL, 5 mL vial
5 mL, Multiple-Dose Vial: NDC 70121-1451-1
5 mL, 25 Multiple-Dose Vials in a Carton: NDC 70121-1451-5

4 mg/mL, 30 mL vial
30 mL, Multiple-Dose Vial in a Carton: NDC 70121-1452-1

Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CAUTION: Federal law prohibits dispensing without a prescription.

Discard unused portion of single-dose vials.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Parenteral Unit

Ahmedabad 382213, INDIA

Distributed by:

Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 07-2020-02

PRINCIPAL DISPLAY PANEL

NDC 70121-1450-1

Dexamethasone sodium phosphate injection USP, 4 mg/mL

1 mL Single-dose Vial

Vial Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1450-5

Dexamethasone sodium phosphate injection USP, 4 mg/mL

1 mL Single-dose Vial

Carton Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1451-1

Dexamethasone sodium phosphate injection USP, 4 mg/mL

5 mL Multiple-dose Vial

Vial Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1451-5

Dexamethasone sodium phosphate injection USP, 4 mg/mL

5 mL Multiple-dose Vial

Carton Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1452-1

Dexamethasone sodium phosphate injection USP, 4 mg/mL

30 mL Multiple-dose Vial

Vial Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 70121-1452-1

Dexamethasone sodium phosphate injection USP, 4 mg/mL

30 mL Multiple-dose Vial

Carton Label

Rx only

Amneal Pharmaceuticals LLC

1
(click image for full-size original)
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1450
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 (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE 1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM CITRATE
WATER
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70121-1450-5 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70121-1450-1)
1 NDC:70121-1450-1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70121-1450-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208689 08/27/2018
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1451
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 (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE 1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM CITRATE
WATER
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70121-1451-5 25 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (70121-1451-1)
1 NDC:70121-1451-1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70121-1451-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208689 08/27/2018
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1452
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 (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFITE 1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM CITRATE
WATER
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70121-1452-1 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70121-1452-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208689 08/27/2018
Labeler — Amneal Pharmaceuticals LLC (827748190)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited, Parenteral Unit 860156658 ANALYSIS (70121-1450), ANALYSIS (70121-1451), ANALYSIS (70121-1452), MANUFACTURE (70121-1450), MANUFACTURE (70121-1451), MANUFACTURE (70121-1452), PACK (70121-1450), PACK (70121-1451), PACK (70121-1452), STERILIZE (70121-1450), STERILIZE (70121-1451), STERILIZE (70121-1452)

Revised: 07/2020 Amneal Pharmaceuticals LLC

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