NDC 50268-476

LETROZOLE

Letrozole

LETROZOLE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Letrozole.

Product ID50268-476_93f329f2-c043-09b4-e053-2a95a90a8120
NDC50268-476
Product TypeHuman Prescription Drug
Proprietary NameLETROZOLE
Generic NameLetrozole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-10-02
Marketing CategoryANDA / ANDA
Application NumberANDA200161
Labeler NameAvPAK
Substance NameLETROZOLE
Active Ingredient Strength3 mg/1
Pharm ClassesAromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50268-476-15

50 BLISTER PACK in 1 BOX (50268-476-15) > 1 TABLET in 1 BLISTER PACK (50268-476-11)
Marketing Start Date2019-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-476-11 [50268047611]

LETROZOLE TABLET
Marketing CategoryANDA
Application NumberANDA200161
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-02

NDC 50268-476-15 [50268047615]

LETROZOLE TABLET
Marketing CategoryANDA
Application NumberANDA200161
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-02

Drug Details

Active Ingredients

IngredientStrength
LETROZOLE2.5 mg/1

OpenFDA Data

SPL SET ID:93f317f1-96d1-498e-e053-2995a90ac60d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200064
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    69117-0004LetrozoleLetrozole Tablets
    70518-1869LetrozoleLetrozole
    70518-2020LetrozoleLetrozole
    71335-1526LETROZOLELETROZOLE
    0078-0249Femaraletrozole

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