NDC 30237-8900

PROVENGE

Sipuleucel-t

PROVENGE is a Intravenous Injection in the Cellular Therapy category. It is labeled and distributed by Dendreon Pharmaceuticals Llc. The primary component is Sipuleucel-t.

• Product ID: 30237-8900_0241032b-c5aa-43c4-994c-e07c5642a1c1
• NDC: 30237-8900
• Product Type: Cellular Therapy
• Proprietary Name: PROVENGE
• Generic Name: Sipuleucel-t
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-04-29
• Marketing Category: BLA / BLA
• Application Number: BLA125197
• Labeler Name: Dendreon Pharmaceuticals LLC
• Substance Name: SIPULEUCEL-T
• Active Ingredient Strength: 50000000 1/1
• Pharm Classes: Autologous Cellular Immunotherapy [EPC],Cell-mediated Immunity [PE],Cells, Cultured, Autologous [EXT],Leukocytes, Mononuclear [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 30237-8900-6

1 BAG in 1 CARTON (30237-8900-6) > 1 INJECTION in 1 BAG (30237-8900-5)

• Marketing Start Date: 2010-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 30237-8900-6 [30237890006]

PROVENGE INJECTION

• Marketing Category: BLA
• Application Number: BLA125197
• Product Type: CELLULAR THERAPY
• Billing Unit: ML
• Marketing Start Date: 2010-04-29

Drug Details

Active Ingredients

Ingredient	Strength
SIPULEUCEL-T	50000000 1/1

Pharmacological Class

• Autologous Cellular Immunotherapy [EPC]
• Cell-mediated Immunity [PE]
• Cells
• Cultured
• Autologous [EXT]
• Leukocytes
• Mononuclear [CS]