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 ID: 0517-0602_134f916d-279e-4848-829a-ddb423b2a837
• NDC: 0517-0602
• Product Type: Human Prescription Drug
• Proprietary Name: Injectafer
• Generic Name: Ferric Carboxymaltose Injection
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2022-06-01
• Marketing Category: NDA /
• Application Number: NDA203565
• Labeler Name: American Regent, Inc.
• Substance Name: FERRIC CARBOXYMALTOSE
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0517-0602-01

1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) > 2 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2022-07-28
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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

NDC	Brand Name	Generic Name
0517-0602	Injectafer	Ferric Carboxymaltose Injection
0517-0620	Injectafer	Ferric Carboxymaltose
0517-0650	Injectafer	Ferric Carboxymaltose Injection