NDC 0078-0249

Femara

Letrozole

Femara is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Letrozole.

Product ID0078-0249_0e5750b1-fbed-43cf-8611-b222a193ac8c
NDC0078-0249
Product TypeHuman Prescription Drug
Proprietary NameFemara
Generic NameLetrozole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1997-07-31
Marketing CategoryNDA / NDA
Application NumberNDA020726
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameLETROZOLE
Active Ingredient Strength3 mg/1
Pharm ClassesAromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0078-0249-15

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15)
Marketing Start Date1997-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0249-15 [00078024915]

Femara TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020726
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-07-31

Drug Details

Active Ingredients

IngredientStrength
LETROZOLE2.5 mg/1

OpenFDA Data

SPL SET ID:82b77d74-085f-45ac-a7dd-1f5c038bf406
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200064
  • 153124

    • Pharmacological Class

    • Aromatase Inhibitor [EPC]
    • Aromatase Inhibitors [MoA]

    NDC Crossover Matching brand name "Femara" or generic name "Letrozole"

    NDCBrand NameGeneric Name
    0078-0249Femaraletrozole
    0093-7620LetrozoleLetrozole
    16729-034Letrozoleletrozole
    17856-0032Letrozoleletrozole
    24535-0801LETROZOLELETROZOLE
    24724-030LETROZOLELETROZOLE
    42254-243LetrozoleLetrozole
    42291-374LetrozoleLetrozole
    50090-3474Letrozoleletrozole
    50268-476LETROZOLELETROZOLE
    51991-759LETROZOLELETROZOLE
    55111-646LetrozoleLetrozole
    57884-2021LETROZOLELETROZOLE
    59651-180LetrozoleLetrozole
    60505-3255LetrozoleLetrozole
    62135-491LETROZOLELetrozole
    62756-511LETROZOLELETROZOLE
    63629-7819Letrozoleletrozole
    63850-0025LetrozoleLetrozole
    65841-744letrozoleletrozole
    68071-5264Letrozoleletrozole
    68084-803LetrozoleLetrozole
    68382-363letrozoleletrozole
    70518-1869Letrozoleletrozole

    Trademark Results [Femara]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FEMARA
    FEMARA
    78534382 3272822 Dead/Expired
    Novartis Corporation
    2004-12-17
    FEMARA
    FEMARA
    78494573 not registered Dead/Abandoned
    Novartis AG
    2004-10-05
    FEMARA
    FEMARA
    75041701 2182663 Live/Registered
    NOVARTIS CORPORATION
    1996-01-11
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.