Home NDC 69639-120 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 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# Additional Listing Data#
Finished product Yes
Brand name base VALCHLOR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MECHLORETHAMINE .012 g/60g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 50D9XSG0VR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1437711 Internal RxNorm lookup 1437713 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69639-120-01 VALCHLOR 1 in 1 CARTON GEL 1 12 69639-120-01 VALCHLOR 60 g in 1 TUBE GEL 60 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69639-120 VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [HELSINN THERAPEUTICS (U.S.), INC.] 12 Current NDC, Legacy NDC, 2 package rows 20241123_6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57.zip
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 ndc (product): 69639-120
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69639-120-01 69639012001 1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE 1 tube 2018-11-08 0000-00-00 No No Current