Home NDC 66215-016 VALCHLOR
Product NDC 66215-016
11-digit product format 662150016
Labeler code 66215
Product ID 66215-016_6315be05-3669-4a64-af95-3961b25c8c93
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mechlorethamine hydrochloride
Dosage form GEL
Route TOPICAL
Labeler Actelion Pharmaceuticals US, Inc.
Application NDA202317
Marketing category NDA
Marketing start 2013-10-21
Marketing end 2020-05-31
Substance MECHLORETHAMINE
Active strength 0 g/60g
Pharmacologic classes Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66215-016-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66215-016-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66215-016-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66215-016-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66215-016-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66215-016-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66215-016-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66215-016-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66215-016-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66215-016-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66215-016-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66215-016-60 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202317-001 VALCHLOR MECHLORETHAMINE HYDROCHLORIDE EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202317-001 7838564 2026-03-07 Drug product 2013-09-13 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 N202317-001 7872050 2029-07-08 U-1427 2013-09-13
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 2680178bc6a6…
Observed Orange Book exclusivity history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MECHLORETHAMINE ACTIVE INGREDIENT 50D9XSG0VR VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 MECHLORETHAMINE ACTIVE MOIETY 50D9XSG0VR VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 DIETHYLENE GLYCOL MONOETHYL ETHER INACTIVE INGREDIENT A1A1I8X02B VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 RACEMENTHOL INACTIVE INGREDIENT YS08XHA860 VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [ACTELION PHARMACEUTICALS US, INC.] 5
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VALCHLOR MECHLORETHAMINE HYDROCHLORIDE Helsinn Therapeutics (U.S.), Inc. 6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57 2024-11-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 202317 application number: NDA202317