NDC 0069-0231

Lorbrena

Lorlatinib

Lorbrena is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Lorlatinib.

Product ID0069-0231_4b051995-d812-4f93-87a1-6f53431bf7dc
NDC0069-0231
Product TypeHuman Prescription Drug
Proprietary NameLorbrena
Generic NameLorlatinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-11-19
Marketing CategoryNDA / NDA
Application NumberNDA210868
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameLORLATINIB
Active Ingredient Strength100 mg/1
Pharm ClassesKinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0069-0231-01

30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01)
Marketing Start Date2018-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0231-01 [00069023101]

Lorbrena TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210868
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-19

Drug Details

Active Ingredients

IngredientStrength
LORLATINIB100 mg/1

OpenFDA Data

SPL SET ID:2b34d62d-e02a-4af3-bc0d-1571dd4ee76d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2103177
  • 2103175
  • 2103169
  • 2103179
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Kinase Inhibitors [MoA]
    • Cytochrome P450 3A4 Inducers [MoA]

    NDC Crossover Matching brand name "Lorbrena" or generic name "Lorlatinib"

    NDCBrand NameGeneric Name
    0069-0227Lorbrenalorlatinib
    0069-0231Lorbrenalorlatinib

    Trademark Results [Lorbrena]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LORBRENA
    LORBRENA
    86821577 5396892 Live/Registered
    Pfizer Inc.
    2015-11-16

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