NDC 68152-108

Beleodaq

Belinostat

Beleodaq is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Spectrum Pharmaceuticals, Inc.. The primary component is Belinostat.

• Product ID: 68152-108_8361737e-fcce-4a93-97ca-1220b1132979
• NDC: 68152-108
• Product Type: Human Prescription Drug
• Proprietary Name: Beleodaq
• Generic Name: Belinostat
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-07-21
• Marketing Category: NDA / NDA
• Application Number: NDA206256
• Labeler Name: Spectrum Pharmaceuticals, Inc.
• Substance Name: BELINOSTAT
• Active Ingredient Strength: 500 mg/10mL
• Pharm Classes: Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 68152-108-09

1 VIAL, SINGLE-DOSE in 1 CARTON (68152-108-09) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2014-07-21
• Marketing End Date: 2022-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68152-108-09 [68152010809]

Beleodaq INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA206256
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-07-21

Drug Details

Active Ingredients

Ingredient	Strength
BELINOSTAT	500 mg/10mL

OpenFDA Data

• SPL SET ID: 84b2e16e-f0d1-4757-8da8-79dfa83aab79
• Manufacturer:
  • Spectrum Pharmaceuticals, Inc.
• UNII:
  • F4H96P17NZ
• RxNorm Concept Unique ID - RxCUI:
  • 1543552
  • 1543547
• UPC Code:
  • 0368152108099

Pharmacological Class

• Histone Deacetylase Inhibitor [EPC]
• Histone Deacetylase Inhibitors [MoA]
• Histone Deacetylase Inhibitor [EPC]
• Histone Deacetylase Inhibitors [MoA]

NDC Crossover Matching brand name "Beleodaq" or generic name "Belinostat"

NDC	Brand Name	Generic Name
68152-108	Beleodaq	Belinostat
69605-002	Beleodaq	Belinostat
72893-002	Beleodaq	Belinostat