NDC 70518-1869

Letrozole

Letrozole

Letrozole is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Letrozole.

Product ID70518-1869_82e77eea-2bd9-955e-e053-2a91aa0ab457
NDC70518-1869
Product TypeHuman Prescription Drug
Proprietary NameLetrozole
Generic NameLetrozole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-02-13
Marketing CategoryANDA / ANDA
Application NumberANDA090934
Labeler NameREMEDYREPACK INC.
Substance NameLETROZOLE
Active Ingredient Strength3 mg/1
Pharm ClassesAromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1869-0

30 POUCH in 1 BOX, UNIT-DOSE (70518-1869-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-1869-1)
Marketing Start Date2019-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1869-1 [70518186901]

Letrozole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090934
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

NDC 70518-1869-0 [70518186900]

Letrozole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090934
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

Drug Details

Active Ingredients

IngredientStrength
LETROZOLE2.5 mg/1

OpenFDA Data

SPL SET ID:fd3b21d8-8323-41b8-8de9-b807dad29e56
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200064

    • Pharmacological Class

    • 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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