NDC 75854-321

Niferex

Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, Succinic Acid, And Intrinsic Factor

Niferex is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avion Pharmaceuticals, Llc. The primary component is Ferrous Asparto Glycinate; Iron Dextran; Ascorbic Acid; Levomefolic Acid; Folic Acid; Cyanocobalamin; Zinc; Succinic Acid; Intrinsic Factor.

• Product ID: 75854-321_78267520-cb56-461e-9271-f1ffa21a8b26
• NDC: 75854-321
• Product Type: Human Prescription Drug
• Proprietary Name: Niferex
• Generic Name: Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, Succinic Acid, And Intrinsic Factor
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-01-23
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Avion Pharmaceuticals, LLC
• Substance Name: FERROUS ASPARTO GLYCINATE; IRON DEXTRAN; ASCORBIC ACID; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; ZINC; SUCCINIC ACID; INTRINSIC FACTOR
• Active Ingredient Strength: 50 mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1
• Pharm Classes: Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B 12 [CS],Vitamin B12 [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 75854-321-30

30 TABLET in 1 BOTTLE (75854-321-30)

• Marketing Start Date: 2017-01-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75854-321-30 [75854032130]

Niferex TABLET

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-10

Drug Details

Active Ingredients

Ingredient	Strength
FERROUS ASPARTO GLYCINATE	50 mg/1

OpenFDA Data

• SPL SET ID: 899f97fb-85f1-4e78-9708-b916a1646129
• Manufacturer:
  • Avion Pharmaceuticals, LLC
• UNII:
  • AB6MNQ6J6L
  • 95HR524N2M
  • J41CSQ7QDS
  • 70BT6OQT2Q
  • PQ6CK8PD0R
  • H7426RGB3L
  • 8S95DH25XC
  • 935E97BOY8
  • P6YC3EG204

Pharmacological Class

• Iron [CS]
• Parenteral Iron Replacement [EPC]
• Phosphate Binder [EPC]
• Phosphate Chelating Activity [MoA]
• Vitamin C [EPC]
• Ascorbic Acid [CS]
• Vitamin B 12 [CS]
• Vitamin B12 [EPC]