NDC Code(s) : 0517-0134-10, 0517-0234-10
Packager : American Regent, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexferrumiron dextran INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0134
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON DEXTRAN(UNII: 95HR524N2M)
(FERRIC CATION - UNII:91O4LML611) 		FERRIC CATION50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0134-1010 in 1 BOX
11 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA040024 10/01/1998
Dexferrumiron dextran INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0234
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON DEXTRAN(UNII: 95HR524N2M)
(FERRIC CATION - UNII:91O4LML611) 		FERRIC CATION50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0234-1010 in 1 BOX
12 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA040024 03/01/1996

PRINCIPAL DISPLAY PANEL

CONTAINER

NDC 0517-0134-10

DEXFERRUM® (IRON DEXTRAN INJECTION, USP)

50 mg Elemental Iron per mL

1 mL SINGLE DOSE VIAL

FOR IV USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

1 mL Container

CARTON

NDC 0517-0134-10

10 x 1 mL SINGLE DOSE VIALS

DEXFERRUM® (IRON DEXTRAN INJECTION, USP)

50 mg Elemental Iron per mL

1 mL SINGLE DOSE VIAL

FOR INTRAVENOUS USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

U.S. PATENT 5,624,668
1 mL Container

PRINCIPAL DISPLAY PANEL

CONTAINER

NDC 0517-0234-10

DEXFERRUM® (IRON DEXTRAN INJECTION, USP)

100 mg Elemental Iron per 2 mL (50 mg/mL)

2 mL SINGLE DOSE VIAL

FOR IV USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

2 mL Container

CARTON

NDC 0517-0234-10

10 x 2 mL SINGLE DOSE VIALS

DEXFERRUM® (IRON DEXTRAN INJECTION, USP)

100 mg Elemental Iron per 2 mL (50 mg/mL)

2 mL SINGLE DOSE VIAL

FOR INTRAVENOUS USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

U.S. PATENT 5,624,668

2 mL Container