VALCHLOR

Product NDC
69639-120
11-digit product format
696390120
Labeler code
69639
Product ID
69639-120_942707af-a16c-4a62-b733-103e0fac915e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mechlorethamine hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Helsinn Therapeutics (U.S.), Inc.
Application
NDA202317
Marketing category
NDA
Marketing start
2018-11-08
Substance
MECHLORETHAMINE
Active strength
.012 g/60g
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VALCHLOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECHLORETHAMINE.012 g/60g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50D9XSG0VR
Rxcui1437711, 1437713

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c1f52d66-9004-4964-a5bc-014f7ab49af1Product name120200610

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69639-120-01VALCHLOR1 in 1 CARTONGEL112
69639-120-01VALCHLOR60 g in 1 TUBEGEL6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69639-120-01GM - Gram69639-1209680743d-51c8-4395-95c0-e8d419dacdc012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69639-120VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [HELSINN THERAPEUTICS (U.S.), INC.]12Current NDC, Legacy NDC, 2 package rows20241123_6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437711mechlorethamine 0.016 % Topical GelPSN6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd5712
1437713VALCHLOR 0.016 % Topical GelPSN6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd5712
1437713mechlorethamine 0.00016 MG/MG Topical Gel [Valchlor]SBD6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd5712
1437711mechlorethamine 0.00016 MG/MG Topical GelSCD6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd5712
1437711mechlorethamine 0.016 % Topical GelSY6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd5712
1437713Valchlor 0.00016 MG/MG Topical GelSY6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd5712
1437713Valchlor 0.016 % Topical GelSY6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd5712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69639-120-01696390120011 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE1 tube2018-11-080000-00-00NoNoCurrent