NDC 0517-0602

Injectafer

Ferric Carboxymaltose Injection

Injectafer is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Ferric Carboxymaltose.

Product ID0517-0602_134f916d-279e-4848-829a-ddb423b2a837
NDC0517-0602
Product TypeHuman Prescription Drug
Proprietary NameInjectafer
Generic NameFerric Carboxymaltose Injection
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-06-01
Marketing CategoryNDA /
Application NumberNDA203565
Labeler NameAmerican Regent, Inc.
Substance NameFERRIC CARBOXYMALTOSE
Active Ingredient Strength50 mg/mL
Pharm ClassesIron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0517-0602-01

1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2022-07-28
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Injectafer" or generic name "Ferric Carboxymaltose Injection"

NDCBrand NameGeneric Name
0517-0602InjectaferFerric Carboxymaltose Injection
0517-0620InjectaferFerric Carboxymaltose
0517-0650InjectaferFerric Carboxymaltose Injection

Trademark Results [Injectafer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INJECTAFER
INJECTAFER
87023433 5154434 Live/Registered
Vifor (International) AG (Vifor (International) Ltd.) (Vifor (International) Inc.)
2016-05-03
INJECTAFER
INJECTAFER
79073036 3811137 Dead/Cancelled
Vifor (International) AG (Vifor (International) Ltd.) (Vifor (International) Inc.)
2009-08-28
INJECTAFER
INJECTAFER
79068076 3728704 Live/Registered
Vifor (International) AG; (Vifor (International) Ltd.); (Vifor (International) Inc.)
2009-04-07
INJECTAFER
INJECTAFER
78743098 not registered Dead/Abandoned
Vifor (International) AG (Vifor (International) Ltd.) (Vifor (International) Inc.)
2005-10-29

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