Retacrit (Epoetin alfa-epbx) NDC 59353-002

Product information

Brand name (proprietary)

Retacrit

Generic name (nonproprietary)

epoetin alfa-epbx

Active ingredients

Epoetin — 2000 [iU]/mL

Dosage form

Injection, Solution

Route

Intravenous, Subcutaneous

Labeler

Vifor (International) Inc.NDC labeler code 59353

Product type

Prescription drug

Marketing category

BLA — Biologics License ApplicationApplication BLA 125545

Marketing start

Jun 18, 2018

Listing expires

Dec 31, 2026

Other FDA classes

Erythropoietin (Chemical structure)Increased Erythroid Cell Production (Physiologic effect)

Identifiers

Product ID 59353-002_5626304b-344f-4155-9afa-d7cfe733d819SPL ID 5626304b-344f-4155-9afa-d7cfe733d819SPL set ID e6e4dd0c-25ca-40b2-ba6b-6138a68621feRxCUI 2047591, 2047596, 2047600, 2047602, 2047606, 2047608, 2047612, 2047614, 2463731, 2463733, 2463735, 2463737UNII 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

N459353000210 followed by a unit qualifier and the quantity Copy

Package 59353-0002-10. 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

About NDC 59353-002

What is NDC 59353-002?

59353-002 is the product NDC for Retacrit (epoetin alfa-epbx), Epoetin 2000 [iU]/mL injection, solution, listed with the FDA by Vifor (International) Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Retacrit (Epoetin alfa-epbx).

What is the active ingredient?

Epoetin.

Who is the labeler?

Vifor (International) Inc., NDC labeler code 59353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Retacrit?

12 other product NDCs are listed under this name. See all Retacrit NDCs.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory. See Billing references above.

Related NDCs: other Retacrit products

Other finished products listed under the same name: strengths, forms and labelers.

All 13 Retacrit NDCs

Other NDCs under BLA 125545

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