NDC codes

FDA NDC Directory
Product NDC (as listed)30237-8900Labeler and product segments. Claims need a package NDC.
Product NDC at billing width30237-8900Add 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
30237-8900-6302378900061 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.

How CPT relates to drug billing

NDC on a medical claim

N430237890006 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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