NDC 0310-0610

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 ID0310-0610_22af3f74-b305-49e7-81db-a6656a30518a
NDC0310-0610
Product TypeHuman Prescription Drug
Proprietary NameKOSELUGO
Generic NameSelumetinib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-04-16
Marketing CategoryNDA / NDA
Application NumberNDA213756
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameSELUMETINIB
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0310-0610-28

28 CAPSULE in 1 BOTTLE (0310-0610-28)
Marketing Start Date2021-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-0610-60 [00310061060]

KOSELUGO CAPSULE
Marketing CategoryNDA
Application NumberNDA213756
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-16

Drug Details

Active Ingredients

IngredientStrength
SELUMETINIB10 mg/1

OpenFDA Data

SPL SET ID:7d042c61-f28f-4ab5-ab10-d7558c0d49ff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2289426
  • 2289424
  • 2289428
  • 2289418
  • NDC Crossover Matching brand name "KOSELUGO" or generic name "Selumetinib"

    NDCBrand NameGeneric Name
    0310-0610KOSELUGOSELUMETINIB
    0310-0625KOSELUGOSELUMETINIB

    Trademark Results [KOSELUGO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KOSELUGO
    KOSELUGO
    88639031 not registered Live/Pending
    AstraZeneca AB
    2019-10-02

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