NDC Code(s) : 67457-423-00, 67457-423-12, 67457-422-00, 67457-422-54, 67457-421-00, 67457-421-30, 67457-420-00, 67457-420-10
Packager : Mylan Institutional LLC

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:67457-423
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(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:67457-423-1225 in 1 CARTON 05/11/2011
1NDC:67457-423-001 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:67457-422
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(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:67457-422-5425 in 1 CARTON 05/11/2011
1NDC:67457-422-005 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:67457-421
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(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:67457-421-3025 in 1 CARTON 05/11/2011
1NDC:67457-421-0030 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:67457-420
Route of Administration INTRAMUSCULAR, INTRAVENOUS 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:67457-420-1010 in 1 CARTON 05/11/2011
1NDC:67457-420-0010 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

LABELER - Mylan Institutional LLC(790384502)

PRINCIPAL DISPLAY PANEL

NDC 67457-420-10

Dexamethasone
Sodium Phosphate
Injection, USP

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

Sterile

For IM or IV use only

Rx only

10 x 10 mL Multi-Dose Vials

*Each mL contains:
Active: Dexamethasone Sodium Phosphate 11 mg
(eq. to Dexamethasone Phosphate 10 mg)

Preservatives: Methylparaben 1.5 mg;
Propylparaben 0.2 mg

Inactives: Edetate Disodium 0.11 mg; Sodium
Citrate 10 mg; Citric Acid and/or Sodium Hydroxide
to adjust pH (7.0 to 8.5); and Water for Injection q.s.
to 1 mL.

Usual Dosage: See package insert.

Storage: Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]

Protect from light. Sensitive to heat.

Do not autoclave. Protect from freezing.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: TN/DRUGS/TN00003234

Mylan.com

NDC 67457-20-10

PRINCIPAL DISPLAY PANEL

NDC 67457-421-30

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

25 x 30 mL Multi-Dose Vials

*Each mL contains:
Active: Dexamethasone Sodium Phosphate 4.4 mg
(eq. to Dexamethasone Phosphate 4 mg)

Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg

Inactives: Edetate Disodium 0.11 mg; Sodium Citrate 10 mg; Citric Acid and/or
Sodium Hydroxide to adjust pH (7.0 to 8.5); and Water for Injection q.s. to 1 mL.

Usual Dosage: See package insert.

Storage: Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]

Protect from light. Sensitive to heat.

Do not autoclave. Protect from freezing.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: TN/DRUGS/TN00003234

Mylan.com

NDC 67457-421-30

PRINCIPAL DISPLAY PANEL

NDC 67457-422-54

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

25 x 5 mL Multi-Dose Vials

*Each mL contains:
Active: Dexamethasone Sodium Phosphate 4.4 mg
(eq. to Dexamethasone Phosphate 4 mg)

Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg

Inactives: Edetate Disodium 0.11 mg; Sodium Citrate 10 mg; Citric Acid and/or
Sodium Hydroxide to adjust pH (7.0 to 8.5); and Water for Injection q.s. to 1 mL.

Usual Dosage: See package insert.

Storage: Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]

Protect from light. Sensitive to heat.

Do not autoclave. Protect from freezing.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: TN/DRUGS/TN00003234

Mylan.com

NDC 67457-422-54

PRINCIPAL DISPLAY PANEL

NDC 67457-423-12

Dexamethasone
Sodium Phosphate
Injection, USP

4 mg/mL*

Sterile

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

Rx only

25 x 1 mL Single-Dose Vials

*Each mL contains:
Active: Dexamethasone Sodium Phosphate 4.4 mg
(eq. to Dexamethasone Phosphate 4 mg)

Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg

Inactives: Edetate Disodium 0.11 mg; Sodium Citrate 10 mg;
Citric Acid and/or Sodium Hydroxide to adjust pH (7.0 to 8.5);
and Water for Injection q.s. to 1 mL.

Usual Dosage: See package insert.

Storage: Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]

Protect from light. Sensitive to heat.

Do not autoclave. Protect from freezing.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: TN/DRUGS/TN00003234

Mylan.com

NDC 67457-423-12