o WWW.INJECTAFER.COM or call 1-800-734-9236.
This Patient information has been approved by the U.S. Food and Drug Administration.
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Revised: 04/2018
PRINCIPAL DISPLAY PANEL - 15 ML CONTAINER
NDC 0517-0650-01
Injectafer®
(ferric carboxymaltose injection)
750 mg/15 mL
(50 mg/mL)
FOR INTRAVENOUS USE ONLY
Single Dose Vial. Discard Unused Portion.
Rx Only
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Container Label
PRINCIPAL DISPLAY PANEL - 15 ML CARTON (SINGLE PACK)
NDC 0517-0650-01
Injectafer®
(ferric carboxymaltose injection)
750 mg/15 mL
(50 mg/mL)
FOR INTRAVENOUS USE ONLY
Single Dose Vial.
Discard Unused Portion.
Rx Only
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Carton Labeling
PRINCIPAL DISPLAY PANEL - 15 ML CARTON (2-PACK)
NDC 0517-0650-02
Injectafer®
(ferric carboxymaltose injection)
750 mg/15 mL
(50 mg/mL)
FOR INTRAVENOUS USE ONLY
Two 15-mL Single Dose Vials.
Discard Unused Portion.
Rx Only
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
2 pack Carton labeling
INGREDIENTS AND APPEARANCE
INJECTAFER
ferric carboxymaltose injection injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0650
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERRIC CARBOXYMALTOSE (UNII: 6897GXD6OE) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0517-0650-01 1 in 1 BOX 08/12/2013
1 15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
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