PROVENGE
- Product NDC
- 30237-8900
- 11-digit product format
- 302378900
- Labeler code
- 30237
- Product ID
- 30237-8900_4044189e-1cb5-b6f5-e063-6394a90aeb7e
- Type
- CELLULAR THERAPY
- Nonproprietary name
- sipuleucel-T
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Dendreon Pharmaceuticals LLC
- Application
- BLA125197
- Marketing category
- BLA
- Marketing start
- 2010-04-29
- Substance
- SIPULEUCEL-T
- Active strength
- 50000000 1/1
- Pharmacologic classes
- Autologous Cellular Immunotherapy [EPC], Cell-mediated Immunity [PE], Cells, Cultured, Autologous [EXT], Leukocytes, Mononuclear [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROVENGE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIPULEUCEL-T | 50000000 1/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8Q622VDR18 |
| Rxcui | 997264, 997267 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 30237-8900-5 | PROVENGE | 1 in 1 BAG | INJECTION | 1 | | 19 |
| 30237-8900-6 | PROVENGE | 1 in 1 CARTON | INJECTION | 1 | | 19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 30237-8900 | PROVENGE (SIPULEUCEL-T) INJECTION [DENDREON PHARMACEUTICALS LLC] | 18 | Current NDC, Legacy NDC, 2 package rows | 20241012_8309b497-5d4e-4408-ac0c-2452c11c8a35.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 997267 | PROVENGE 50,000,000 CELLS in 250 ML Injection | PSN | 8309b497-5d4e-4408-ac0c-2452c11c8a35 | 19 |
| 997264 | sipuleucel-T 50,000,000 CELLS in 250 ML Injection | PSN | 8309b497-5d4e-4408-ac0c-2452c11c8a35 | 19 |
| 997267 | 250 ML sipuleucel-T 200000 CELLS/ML Injection [Provenge] | SBD | 8309b497-5d4e-4408-ac0c-2452c11c8a35 | 19 |
| 997264 | 250 ML sipuleucel-T 200000 CELLS/ML Injection | SCD | 8309b497-5d4e-4408-ac0c-2452c11c8a35 | 19 |
| 997267 | Provenge (minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF per 250 ML of Lactated Ringer's) Injection | SY | 8309b497-5d4e-4408-ac0c-2452c11c8a35 | 19 |
| 997267 | Provenge 50,000,000 CELLS per 250 ML Injection | SY | 8309b497-5d4e-4408-ac0c-2452c11c8a35 | 19 |
| 997264 | sipuleucel-T 50,000,000 CELLS per 250 ML Injection | SY | 8309b497-5d4e-4408-ac0c-2452c11c8a35 | 19 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 30237-8900-5 | 30237890005 | 1 in 1 BAG | | | | | | Historical |
| 30237-8900-6 | 30237890006 | 1 BAG in 1 CARTON (30237-8900-6) / 1 INJECTION in 1 BAG (30237-8900-5) | 1 bag | 2010-04-29 | 0000-00-00 | No | No | Current |