NDC 0517-2325

Venofer

Iron Sucrose

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

• Product ID: 0517-2325_0397137f-282f-44f7-95ad-34bb90938fef
• NDC: 0517-2325
• Product Type: Human Prescription Drug
• Proprietary Name: Venofer
• Generic Name: Iron Sucrose
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-01-27
• Marketing Category: NDA / NDA
• Application Number: NDA021135
• Labeler Name: American Regent, Inc.
• Substance Name: IRON SUCROSE
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0517-2325-10

10 VIAL, SINGLE-DOSE in 1 BOX (0517-2325-10) > 2.5 mL in 1 VIAL, SINGLE-DOSE (0517-2325-01)

• Marketing Start Date: 2011-01-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0517-2325-10 [00517232510]

Venofer INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021135
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-01-27

NDC 0517-2325-01 [00517232501]

Venofer INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021135
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-02-26

Drug Details

Active Ingredients

Ingredient	Strength
IRON SUCROSE	20 mg/mL

OpenFDA Data

• SPL SET ID: 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a
• Manufacturer:
  • American Regent, Inc.
• UNII:
  • FZ7NYF5N8L
• RxNorm Concept Unique ID - RxCUI:
  • 1741261
  • 1741271
  • 1741263
  • 1741267
  • 1741268
  • 1741270
• UPC Code:
  • 0349230534108
  • 0305172340016
  • 0305172340252

Pharmacological Class

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

NDC Crossover Matching brand name "Venofer" or generic name "Iron Sucrose"

NDC	Brand Name	Generic Name
0517-2310	Venofer	iron sucrose
0517-2325	Venofer	iron sucrose
0517-2340	Venofer	iron sucrose
49230-530	Venofer	iron sucrose
49230-534	Venofer	iron sucrose
50090-4541	Venofer	iron sucrose
58607-111	Myferon 150	IRON SUCROSE