valchlor

Generic: mechlorethamine hydrochloride

Labeler: helsinn therapeutics (u.s.), inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name valchlor
Generic Name mechlorethamine hydrochloride
Labeler helsinn therapeutics (u.s.), inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

mechlorethamine .012 g/60g

Manufacturer
Helsinn Therapeutics (U.S.), Inc.

Identifiers & Regulatory

Product NDC 69639-120
Product ID 69639-120_942707af-a16c-4a62-b733-103e0fac915e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202317
Listing Expiration 2026-12-31
Marketing Start 2018-11-08

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69639120
Hyphenated Format 69639-120

Supplemental Identifiers

RxCUI
1437711 1437713
UPC
0369639120016
UNII
50D9XSG0VR
NUI
N0000000236 N0000175558

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name valchlor (source: ndc)
Generic Name mechlorethamine hydrochloride (source: ndc)
Application Number NDA202317 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .012 g/60g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE
source: ndc

Packages (1)

69639-120-01 1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE

Ingredients (1)

mechlorethamine (.012 g/60g)

Linked Drug Pages (1)

VALCHLOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "942707af-a16c-4a62-b733-103e0fac915e", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0369639120016"], "unii": ["50D9XSG0VR"], "rxcui": ["1437711", "1437713"], "spl_set_id": ["6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Helsinn Therapeutics (U.S.), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69639-120-01)  / 60 g in 1 TUBE", "package_ndc": "69639-120-01", "marketing_start_date": "20181108"}], "brand_name": "VALCHLOR", "product_id": "69639-120_942707af-a16c-4a62-b733-103e0fac915e", "dosage_form": "GEL", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "69639-120", "generic_name": "mechlorethamine hydrochloride", "labeler_name": "Helsinn Therapeutics (U.S.), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VALCHLOR", "active_ingredients": [{"name": "MECHLORETHAMINE", "strength": ".012 g/60g"}], "application_number": "NDA202317", "marketing_category": "NDA", "marketing_start_date": "20181108", "listing_expiration_date": "20261231"}