NDC 0069-1308

RETACRIT

Epoetin Alfa-epbx

RETACRIT is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Erythropoietin.

• Product ID: 0069-1308_096e8e7a-2e35-400b-879c-480b935b5a8a
• NDC: 0069-1308
• 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: Pfizer Laboratories Div Pfizer Inc
• Substance Name: ERYTHROPOIETIN
• Active Ingredient Strength: 10000 [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 0069-1308-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1308-10) > 1 mL in 1 VIAL, SINGLE-DOSE (0069-1308-01)

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

NDC SPL Data Element Entries

NDC 0069-1308-10 [00069130810]

RETACRIT INJECTION, SOLUTION

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

NDC 0069-1308-01 [00069130801]

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	10000 [iU]/mL

OpenFDA Data

• SPL SET ID: 3af26b0d-8ad0-44e1-a538-8bdb5ab39374
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 64FS3BFH5W
• RxNorm Concept Unique ID - RxCUI:
  • 2047606
  • 2047602
  • 2047600
  • 2047608
  • 2047621
  • 2047591
  • 2047596
  • 2047612
  • 2047614
  • 2047623

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