NDC codes

FDA NDC Directory
Product NDC (as listed)73536-500Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73536-0500Add 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 NDC11-digit (billing)PackageCopy
73536-500-01735360500011 SYRINGE, GLASS in 1 CARTON (73536-500-01) / 1 mL in 1 SYRINGE, GLASSMarketed from Nov 12, 2021

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
Generic name (nonproprietary)
ropeginterferon alfa-2b
Active ingredients
Ropeginterferon alfa-2b — 500 ug/mL
Dosage form
Injection
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 73536-500_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.

How CPT relates to drug billing

NDC on a medical claim

N473536050001 followed by a unit qualifier and the quantity

Package 73536-0500-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 73536-500

What is NDC 73536-500?
73536-500 is the product NDC for BESREMi (ropeginterferon alfa-2b), Ropeginterferon alfa-2b 500 ug/mL injection, 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 (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?
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.

FDA NDC Directory listings under BLA 761166
ProductStrengthForm · routeLabelerProduct NDC
BESREMi Penropeginterferon alfa-2bRopeginterferon alfa-2b 500 ug/.5mLInjection, SolutionSubcutaneousPharmaEssentia USA73536-511

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