Epogen (epoetin alfa) NDC 55513-148

NDC codes

FDA NDC Directory

Product NDC (as listed)55513-148Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55513-0148Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
55513-148-10	55513014810	10 VIAL in 1 PACKAGE (55513-148-10) / 1 mL in 1 VIAL (55513-148-01)Marketed from Aug 16, 1993
55513-148-20	55513014820	10 VIAL in 1 PACKAGE (55513-148-20) / 1 mL in 1 VIAL (55513-148-01)Marketed from Apr 14, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Epogen
Generic name (nonproprietary): epoetin alfa
Active ingredients: Epoetin — 4000 [iU]/mL
Dosage form: Solution
Route: Intravenous, Subcutaneous
Labeler: Amgen, Inc
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 103234
Marketing start: Aug 16, 1993
Listing expires: Dec 31, 2027
Other FDA classes: Erythropoietin (Chemical structure)Increased Erythroid Cell Production (Physiologic effect)
Identifiers: Product ID 55513-148_bf994196-5149-4089-b1fc-c4f0cb8744b3SPL ID bf994196-5149-4089-b1fc-c4f0cb8744b3SPL set ID 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5RxCUI 205912, 205917, 205921, 205923, 212218, 239998, 239999, 240000, 240377, 241999, 1721684, 1721685UNII 64FS3BFH5W
Pharmacologic class: Erythropoiesis-stimulating Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N455513014810 followed by a unit qualifier and the quantity

Package 55513-0148-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 23, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). - The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use Epogen has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). Epogen is not indicated for use: I…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 103234

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 103234
Product	Strength	Form · route	Labeler	Product NDC
Procriterythropoietin	Epoetin 2000 [iU]/mL	Injection, SolutionIntravenous, Subcutaneous	Janssen Products, LP	59676-302
Procriterythropoietin	Epoetin 3000 [iU]/mL	Injection, SolutionIntravenous, Subcutaneous	Janssen Products, LP	59676-303
Procriterythropoietin	Epoetin 4000 [iU]/mL	Injection, SolutionIntravenous, Subcutaneous	Janssen Products, LP	59676-304
Procriterythropoietin	Epoetin 10000 [iU]/mL	Injection, SolutionIntravenous, Subcutaneous	Janssen Products, LP	59676-310
Procriterythropoietin	Epoetin 40000 [iU]/mL	Injection, SolutionIntravenous, Subcutaneous	Janssen Products, LP	59676-340
Procriterythropoietin	Epoetin 10000 [iU]/mL	Injection, SolutionIntravenous, Subcutaneous	Janssen Products, LP	59676-312
Procriterythropoietin	Epoetin 20000 [iU]/mL	Injection, SolutionIntravenous, Subcutaneous	Janssen Products, LP	59676-320
Epogenepoetin alfa	Epoetin 2000 [iU]/mL	SolutionIntravenous, Subcutaneous	Amgen, Inc	55513-126
Epogenepoetin alfa	Epoetin 10000 [iU]/mL	SolutionIntravenous, Subcutaneous	Amgen, Inc	55513-144
Epogenepoetin alfa	Epoetin 3000 [iU]/mL	SolutionIntravenous, Subcutaneous	Amgen, Inc	55513-267
Epogenepoetin alfa	Epoetin 10000 [iU]/mL	SolutionIntravenous, Subcutaneous	Amgen, Inc	55513-283
Epogenepoetin alfa	Epoetin 20000 [iU]/mL	SolutionIntravenous, Subcutaneous	Amgen, Inc	55513-478