NDC 0310-1350

TAGRISSO

Osimertinib

TAGRISSO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Osimertinib.

Product ID0310-1350_1c8a97f0-4187-4e77-9b9b-d7a1d8ec6af0
NDC0310-1350
Product TypeHuman Prescription Drug
Proprietary NameTAGRISSO
Generic NameOsimertinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-11-13
Marketing CategoryNDA / NDA
Application NumberNDA208065
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameOSIMERTINIB
Active Ingredient Strength80 mg/1
Pharm ClassesBreast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0310-1350-30

30 TABLET, FILM COATED in 1 BOTTLE (0310-1350-30)
Marketing Start Date2015-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-1350-30 [00310135030]

TAGRISSO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208065
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-13

Drug Details

Active Ingredients

IngredientStrength
OSIMERTINIB80 1/1

OpenFDA Data

SPL SET ID:5e81b4a7-b971-45e1-9c31-29cea8c87ce7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1721583
  • 1721581
  • 1721565
  • 1721571
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Kinase Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 1A2 Inducers [MoA]
    • Breast Cancer Resistance Protein Inhibitors [MoA]

    NDC Crossover Matching brand name "TAGRISSO" or generic name "Osimertinib"

    NDCBrand NameGeneric Name
    0310-1349TAGRISSOosimertinib
    0310-1350TAGRISSOosimertinib

    Trademark Results [TAGRISSO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TAGRISSO
    TAGRISSO
    86827065 5117285 Live/Registered
    AstraZeneca AB
    2015-11-20
    TAGRISSO
    TAGRISSO
    86435845 4930229 Live/Registered
    AstraZeneca AB
    2014-10-27

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