Prescription drug · BLA
Winrevair (Sotatercept-csrk) NDC 0006-5091
Kit · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-5091-01 | 00006509101 | 1 KIT in 1 CARTON (0006-5091-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5069-99) * 1.3 mL in 1 SYRINGE (0006-5080-89)Marketed from Mar 26, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Winrevair
- Generic name (nonproprietary)
- sotatercept-csrk
- Dosage form
- Kit
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761363
- Marketing start
- Listing expires
- Identifiers
- Product ID 0006-5091_12e11c46-abc1-40b8-823e-0be043323f78SPL ID 12e11c46-abc1-40b8-823e-0be043323f78SPL set ID 21693ee2-cd23-4137-ac67-066bb3a4a9b7RxCUI 2678937, 2678943, 2678945, 2678947, 2678948, 2678949, 2678950, 2678951
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.
- NDC on a medical claim
N400006509101followed by a unit qualifier and the quantityPackage 00006-5091-01. 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 .
Indications (excerpt from the label)
WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1) ] . WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death.…
Excerpt only. Read the full label for complete information.
About NDC 0006-5091
- What is NDC 0006-5091?
- 0006-5091 is the product NDC for Winrevair (sotatercept-csrk) kit, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Winrevair (Sotatercept-csrk).
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Winrevair?
- 3 other product NDCs are listed under this name. See all Winrevair NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Winrevair products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Winrevairsotatercept-csrk | — | Kit | Merck Sharp & Dohme LLC | 0006-5090 | 00006-5090-01 |
| Winrevairsotatercept-csrk | — | Kit | Merck Sharp & Dohme LLC | 0006-5087 | 00006-5087-01 |
| Winrevairsotatercept-csrk | — | Kit | Merck Sharp & Dohme LLC | 0006-5088 | 00006-5088-01 |
Other NDCs under BLA 761363
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 |
|---|---|---|---|---|
| Winrevairsotatercept-csrk | — | Kit | Merck Sharp & Dohme LLC | 0006-5090 |
| Winrevairsotatercept-csrk | — | Kit | Merck Sharp & Dohme LLC | 0006-5087 |
| Winrevairsotatercept-csrk | — | Kit | Merck Sharp & Dohme LLC | 0006-5088 |