NDC 0517-0650

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: 0517-0650_134f916d-279e-4848-829a-ddb423b2a837
• NDC: 0517-0650
• Product Type: Human Prescription Drug
• Proprietary Name: Injectafer
• Generic Name: Ferric Carboxymaltose Injection
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-08-12
• Marketing Category: NDA / 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 0517-0650-01

1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) > 15 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2013-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0517-0650-01 [00517065001]

Injectafer INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA203565
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-08-12

NDC 0517-0650-02 [00517065002]

Injectafer INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA203565
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-10-01

Drug Details

Active Ingredients

Ingredient	Strength
FERRIC CARBOXYMALTOSE	50 mg/mL

OpenFDA Data

• SPL SET ID: 517b4a19-45b3-4286-9f6a-ced4e10447de
• Manufacturer:
  • American Regent, Inc.
• UNII:
  • 6897GXD6OE
• RxNorm Concept Unique ID - RxCUI:
  • 1435169
  • 1435174

Pharmacological Class

• Iron [CS]
• Parenteral Iron Replacement [EPC]
• Phosphate Binder [EPC]
• Phosphate Chelating Activity [MoA]

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