Cellular therapy · BLA
Provenge (Sipuleucel-t) NDC 30237-8900
Sipuleucel-t 50000000 1/1 · Injection · Intravenous · Dendreon Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 30237-8900-6 | 30237890006 | 1 BAG in 1 CARTON (30237-8900-6) / 1 INJECTION in 1 BAG (30237-8900-5)Marketed from Apr 29, 2010 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Provenge
- Generic name (nonproprietary)
- sipuleucel-t
- Active ingredients
- Sipuleucel-t — 50000000 1/1
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Dendreon Pharmaceuticals LLCNDC labeler code 30237
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125197
- Marketing start
- Listing expires
- Other FDA classes
- Cell-mediated Immunity (Physiologic effect)Autologous (EXT)Mononuclear (Chemical structure)
- Identifiers
- Product ID 30237-8900_4044189e-1cb5-b6f5-e063-6394a90aeb7eSPL ID 4044189e-1cb5-b6f5-e063-6394a90aeb7eSPL set ID 8309b497-5d4e-4408-ac0c-2452c11c8a35RxCUI 997264, 997267UNII 8Q622VDR18
- Pharmacologic class
- Autologous Cellular Immunotherapy
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
N430237890006followed by a unit qualifier and the quantityPackage 30237-8900-06. 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)
PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 30237-8900
- What is NDC 30237-8900?
- 30237-8900 is the product NDC for Provenge (sipuleucel-t), Sipuleucel-t 50000000 1/1 injection, listed with the FDA by Dendreon Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Provenge (Sipuleucel-T).
- What is the active ingredient?
- Sipuleucel-t.
- Who is the labeler?
- Dendreon Pharmaceuticals LLC, NDC labeler code 30237. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Provenge?
- 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.