NDC 76388-635

LEUKERAN

Chlorambucil

LEUKERAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aspen Global Inc.. The primary component is Chlorambucil.

Product ID76388-635_16f239bb-4f1b-4114-a290-78b3c3a73b36
NDC76388-635
Product TypeHuman Prescription Drug
Proprietary NameLEUKERAN
Generic NameChlorambucil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1985-02-13
Marketing CategoryNDA / NDA
Application NumberNDA010669
Labeler NameAspen Global Inc.
Substance NameCHLORAMBUCIL
Active Ingredient Strength2 mg/1
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 76388-635-25

25 TABLET, FILM COATED in 1 BOTTLE (76388-635-25)
Marketing Start Date1985-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76388-635-50 [76388063550]

LEUKERAN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA010669
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1985-02-13
Marketing End Date2017-10-31

NDC 76388-635-25 [76388063525]

LEUKERAN TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA010669
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1985-02-13

Drug Details

Active Ingredients

IngredientStrength
CHLORAMBUCIL2 mg/1

OpenFDA Data

SPL SET ID:967ed3ff-d99b-41e8-b768-dfb586d3d9a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197462
  • 105553
  • UPC Code
  • 0376388635258
  • Pharmacological Class

    • Alkylating Activity [MoA]
    • Alkylating Drug [EPC]

    Medicade Reported Pricing

    76388063550 LEUKERAN 2 MG TABLET

    Pricing Unit: EA | Drug Type:

    76388063525 LEUKERAN 2 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "LEUKERAN" or generic name "Chlorambucil"

    NDCBrand NameGeneric Name
    69784-610LEUKERANchlorambucil
    76388-635LEUKERANchlorambucil

    Trademark Results [LEUKERAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LEUKERAN
    LEUKERAN
    72008531 0639954 Live/Registered
    BURROUGHS WELLCOME & CO. (U. S. A.) INC.
    1956-05-18

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