Home NDC 64380-752 Methoxsalen
Product NDC 64380-752
11-digit product format 643800752
Labeler code 64380
Product ID 64380-752_2af91a53-9d36-4415-b4f3-cd78b8ad36ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methoxsalen
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA202687
Marketing category ANDA
Marketing start 2016-12-08
Substance METHOXSALEN
Active strength 10 mg/1
Pharmacologic classes Photoabsorption [MoA], Photoactivated Radical Generator [EPC], Photosensitizing Activity [PE], Psoralen [EPC], Psoralens [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64380-752-16 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64380-752-16 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64380-752-16 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64380-752-16 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A202687-001 METHOXSALEN METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202687-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202687-001 METHOXSALEN 10MG CAPSULE / ORAL AB 2014-06-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methoxsalen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOXSALEN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U4VJ29L7BQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1812434 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-752-16 Methoxsalen 50 in 1 BOTTLE, GLASS CAPSULE, LIQUID FILLED 50 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHOXSALEN ACTIVE INGREDIENT U4VJ29L7BQ METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 METHOXSALEN ACTIVE MOIETY U4VJ29L7BQ METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 GLYCINE INACTIVE INGREDIENT TE7660XO1C METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-752 METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED] 7 Current NDC, Legacy NDC, 1 package rows 20250316_a6ec8292-9189-4ebd-862a-e1725eb29eef.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64380-752-16 64380075216 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, GLASS (64380-752-16) 2016-12-08 0000-00-00 No No Current