VALCHLOR
These highlights do not include all the information needed to use VALCHLOR safely and effectively. See full prescribing information for VALCHLOR. VALCHLOR (mechlorethamine) gel, for topical use Initial U.S. Approval: 1949
Approved
Approval ID
6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Helsinn Therapeutics (U.S.), Inc.
DUNS: 829472583
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mechlorethamine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69639-120
Application NumberNDA202317
Product Classification
M
Marketing Category
C73594
G
Generic Name
mechlorethamine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 12, 2020
FDA Product Classification
INGREDIENTS (11)
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
RACEMENTHOLInactive
Code: YS08XHA860
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MECHLORETHAMINEActive
Quantity: 0.012 g in 60 g
Code: 50D9XSG0VR
Classification: ACTIB