NDC 0310-0625

KOSELUGO

Selumetinib

KOSELUGO is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Selumetinib.

• Product ID: 0310-0625_22af3f74-b305-49e7-81db-a6656a30518a
• NDC: 0310-0625
• Product Type: Human Prescription Drug
• Proprietary Name: KOSELUGO
• Generic Name: Selumetinib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2020-04-16
• Marketing Category: NDA / NDA
• Application Number: NDA213756
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: SELUMETINIB
• Active Ingredient Strength: 25 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0310-0625-28

28 CAPSULE in 1 BOTTLE (0310-0625-28)

• Marketing Start Date: 2021-06-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0625-60 [00310062560]

KOSELUGO CAPSULE

• Marketing Category: NDA
• Application Number: NDA213756
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-04-16

Drug Details

Active Ingredients

Ingredient	Strength
SELUMETINIB	25 mg/1

OpenFDA Data

• SPL SET ID: 7d042c61-f28f-4ab5-ab10-d7558c0d49ff
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 6UH91I579U
• RxNorm Concept Unique ID - RxCUI:
  • 2289426
  • 2289424
  • 2289428
  • 2289418

NDC Crossover Matching brand name "KOSELUGO" or generic name "Selumetinib"

NDC	Brand Name	Generic Name
0310-0610	KOSELUGO	SELUMETINIB
0310-0625	KOSELUGO	SELUMETINIB