NDC 66215-016

VALCHLOR

Mechlorethamine Hydrochloride

VALCHLOR is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Actelion Pharmaceuticals Us, Inc.. The primary component is Mechlorethamine.

Product ID66215-016_6315be05-3669-4a64-af95-3961b25c8c93
NDC66215-016
Product TypeHuman Prescription Drug
Proprietary NameVALCHLOR
Generic NameMechlorethamine Hydrochloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2013-10-21
Marketing End Date2020-05-31
Marketing CategoryNDA / NDA
Application NumberNDA202317
Labeler NameActelion Pharmaceuticals US, Inc.
Substance NameMECHLORETHAMINE
Active Ingredient Strength0 g/60g
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN

Packaging

NDC 66215-016-60

1 TUBE in 1 CARTON (66215-016-60) > 60 g in 1 TUBE
Marketing Start Date2013-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66215-016-60 [66215001660]

VALCHLOR GEL
Marketing CategoryNDA
Application NumberNDA202317
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2013-10-21
Marketing End Date2020-05-31

Drug Details

Active Ingredients

IngredientStrength
MECHLORETHAMINE.012 g/60g

OpenFDA Data

SPL SET ID:f522cd6d-aa0f-4b44-92cc-ed952058eea0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1437711
  • 1437713
  • Pharmacological Class

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

    NDC Crossover Matching brand name "VALCHLOR" or generic name "Mechlorethamine Hydrochloride"

    NDCBrand NameGeneric Name
    66215-016VALCHLORmechlorethamine hydrochloride
    69639-120VALCHLORmechlorethamine hydrochloride
    55292-911Mustargenmechlorethamine hydrochloride

    Trademark Results [VALCHLOR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VALCHLOR
    VALCHLOR
    85425856 4538181 Live/Registered
    HELSINN BIREX PHARMACEUTICALS LIMITED
    2011-09-19

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