NDC 58181-3042

Gleostine

Lomustine

Gleostine is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Nextsource Biotechnology, Llc. The primary component is Lomustine.

• Product ID: 58181-3042_29856b4b-0823-4056-a145-638294343a57
• NDC: 58181-3042
• Product Type: Human Prescription Drug
• Proprietary Name: Gleostine
• Generic Name: Lomustine
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-08-18
• Marketing Category: NDA / NDA
• Application Number: NDA017588
• Labeler Name: NextSource Biotechnology, LLC
• Substance Name: LOMUSTINE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58181-3042-5

1 BOTTLE in 1 CARTON (58181-3042-5) > 5 CAPSULE, GELATIN COATED in 1 BOTTLE

• Marketing Start Date: 2014-08-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58181-3042-5 [58181304205]

Gleostine CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA017588
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-18

Drug Details

Active Ingredients

Ingredient	Strength
LOMUSTINE	100 mg/1

OpenFDA Data

• SPL SET ID: 7f77526b-4c40-409c-82ea-d0f934d89cc2
• Manufacturer:
  • NextSource Biotechnology, LLC
• UNII:
  • 7BRF0Z81KG
• RxNorm Concept Unique ID - RxCUI:
  • 197896
  • 197894
  • 197895
  • 1545778
  • 1545776
  • 1545780

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]

NDC Crossover Matching brand name "Gleostine" or generic name "Lomustine"

NDC	Brand Name	Generic Name
58181-3040	Gleostine	lomustine
58181-3041	Gleostine	lomustine
58181-3042	Gleostine	lomustine