NDC 59353-004

RETACRIT

Epoetin Alfa-epbx

RETACRIT is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Vifor (international) Inc.. The primary component is Erythropoietin.

• Product ID: 59353-004_3adf0922-a716-4bad-88b6-983a2e259a44
• NDC: 59353-004
• Product Type: Human Prescription Drug
• Proprietary Name: RETACRIT
• Generic Name: Epoetin Alfa-epbx
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2018-06-18
• Marketing Category: BLA / BLA
• Application Number: BLA125545
• Labeler Name: Vifor (International) Inc.
• Substance Name: ERYTHROPOIETIN
• Active Ingredient Strength: 4000 [iU]/mL
• Pharm Classes: Erythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59353-004-10

10 VIAL, SINGLE-DOSE in 1 CARTON (59353-004-10) > 1 mL in 1 VIAL, SINGLE-DOSE (59353-004-01)

• Marketing Start Date: 2018-06-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59353-004-10 [59353000410]

RETACRIT INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125545
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-18

NDC 59353-004-01 [59353000401]

RETACRIT INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125545
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-18

Drug Details

Active Ingredients

Ingredient	Strength
ERYTHROPOIETIN	4000 [iU]/mL

OpenFDA Data

• SPL SET ID: e6e4dd0c-25ca-40b2-ba6b-6138a68621fe
• Manufacturer:
  • Vifor (International) Inc.
• UNII:
  • 64FS3BFH5W
• RxNorm Concept Unique ID - RxCUI:
  • 2047606
  • 2047602
  • 2047600
  • 2047608
  • 2047591
  • 2047596
  • 2047612
  • 2047614

Pharmacological Class

• Erythropoiesis-stimulating Agent [EPC]
• Erythropoietin [CS]
• Increased Erythroid Cell Production [PE]

NDC Crossover Matching brand name "RETACRIT" or generic name "Epoetin Alfa-epbx"

NDC	Brand Name	Generic Name
0069-1305	RETACRIT	epoetin alfa-epbx
0069-1306	RETACRIT	epoetin alfa-epbx
0069-1307	RETACRIT	epoetin alfa-epbx
0069-1308	RETACRIT	epoetin alfa-epbx
0069-1309	RETACRIT	epoetin alfa-epbx
0069-1311	RETACRIT	epoetin alfa-epbx
0069-1318	RETACRIT	epoetin alfa-epbx
59353-004	RETACRIT	RETACRIT
59353-002	RETACRIT	RETACRIT
59353-003	RETACRIT	RETACRIT
59353-010	RETACRIT	RETACRIT
59353-120	RETACRIT	RETACRIT
59353-220	RETACRIT	RETACRIT