Prescription drug · BLA
BESREMi Pen (Ropeginterferon alfa-2b) NDC 73536-511
Ropeginterferon alfa-2b 500 ug/.5mL · Injection, Solution · Subcutaneous · PharmaEssentia USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73536-511-01 | 73536051101 | 1 CARTRIDGE in 1 CARTON (73536-511-01) / .5 mL in 1 CARTRIDGEMarketed from Jun 25, 2026 |
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)
- BESREMi Pen
- Generic name (nonproprietary)
- ropeginterferon alfa-2b
- Active ingredients
- Ropeginterferon alfa-2b — 500 ug/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- PharmaEssentia USANDC labeler code 73536
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761166
- Marketing start
- Listing expires
- Other FDA classes
- Interferon alfa-2b (Chemical structure)
- Identifiers
- Product ID 73536-511_801f0478-b00c-4e98-90c0-0a32201be6a2SPL ID 801f0478-b00c-4e98-90c0-0a32201be6a2SPL set ID 9583405d-53a0-49dc-88eb-5e6384ebabcbRxCUI 2587064, 2587070, 2748665, 2748670UNII 981TME683S
- Pharmacologic class
- Interferon alfa-2b
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.
- NDC on a medical claim
N473536051101followed by a unit qualifier and the quantityPackage 73536-0511-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.
Excerpt only. Read the full label for complete information.
About NDC 73536-511
- What is NDC 73536-511?
- 73536-511 is the product NDC for BESREMi Pen (ropeginterferon alfa-2b), Ropeginterferon alfa-2b 500 ug/.5mL injection, solution, listed with the FDA by PharmaEssentia USA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BESREMi Pen (Ropeginterferon alfa-2b).
- What is the active ingredient?
- Ropeginterferon alfa-2b.
- Who is the labeler?
- PharmaEssentia USA, NDC labeler code 73536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for BESREMi Pen?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under BLA 761166
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| BESREMiropeginterferon alfa-2b | Ropeginterferon alfa-2b 500 ug/mL | InjectionSubcutaneous | PharmaEssentia USA | 73536-500 |