FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOXSALEN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU4VJ29L7BQ
Rxcui1812434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc0bb075-37ff-40b7-a924-cbc56a34f4dfProduct name220150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
15d6fc22-6acb-ed0a-b9b3-e5121820a5aaProduct name220150105
0695936f-2d11-d8f1-b51f-77f23a458cadProduct name120140508
1a8f0cfc-fa3a-e4fd-a79d-5f18408dcc9eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64380-752-162025-03-13C16284748780-12cef2736-5fdf-d83d-e063-dadaa90ab31fMethoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules]
64380-752-162025-01-30C16284748780-12cef2736-5fdf-d83d-e063-dadaa90ab31fMethoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-752-16Methoxsalen50 in 1 BOTTLE, GLASSCAPSULE, LIQUID FILLED507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-752-16EA - Each64380-752b05ec65d-155c-4828-a287-9a152f4bc25f12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOXSALENACTIVE INGREDIENTU4VJ29L7BQMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
METHOXSALENACTIVE MOIETYU4VJ29L7BQMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
GELATININACTIVE INGREDIENT2G86QN327LMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
GLYCINEINACTIVE INGREDIENTTE7660XO1CMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
SHELLACINACTIVE INGREDIENT46N107B71OMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHOXSALEN CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-752METHOXSALEN CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED]7Current NDC, Legacy NDC, 1 package rows20250316_a6ec8292-9189-4ebd-862a-e1725eb29eef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812434methoxsalen 10 MG Soft Gelatin Oral CapsulePSNa6ec8292-9189-4ebd-862a-e1725eb29eef7
1812434Soft Gelatin methoxsalen 10 MG Oral CapsuleSCDa6ec8292-9189-4ebd-862a-e1725eb29eef7
1812434methoxsalen 10 MG Soft Gelatin Oral CapsuleSYa6ec8292-9189-4ebd-862a-e1725eb29eef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-752-166438007521650 CAPSULE, LIQUID FILLED in 1 BOTTLE, GLASS (64380-752-16) 2016-12-080000-00-00NoNoCurrent