FDA.reportPublic FDA data

Methotrexate

Product NDC
50090-5457
11-digit product format
500905457
Labeler code
50090
Product ID
50090-5457_9a056178-22ac-4049-87ac-226d306eea2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA081099
Marketing category
ANDA
Marketing start
1990-11-01
Substance
METHOTREXATE SODIUM
Active strength
2.5 mg/1
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methotrexate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE SODIUM2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3IG1E710ZN
Rxcui105585

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0Product name920250224
3082de91-569a-4d57-b379-acbf37f1d5c3Product name120210312
f76135bc-a210-42d9-851b-1b73cbaccdb3Product name120200511
423544b2-e325-49ee-8910-4c5dfe41906fProduct name120181120
c9fd924b-0a8d-4d53-bf70-11070e24e4ddProduct name220181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359Product name120181120
eb454f54-2806-4c31-a08b-8dcb08261099Product name220181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27Product name120170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3Product name220160504
88514aea-9d58-4ed2-b135-9811fb14c8fbProduct name120141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5457-22023-02-07C16284748780-1f386c64a-267c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953
50090-5457-92023-02-07C16284748780-1f386c64a-267c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953
50090-5457-22023-01-30C16284748780-1f386c64a-267c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953
50090-5457-92023-01-30C16284748780-1f386c64a-267c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5457-2Methotrexate100 in 1 BOTTLETABLET10015
50090-5457-9Methotrexate36 in 1 BOTTLETABLET3615

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5457METHOTREXATE TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240604_22e10810-16fb-4c84-bccf-972405b77ef8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSN22e10810-16fb-4c84-bccf-972405b77ef815
105585methotrexate 2.5 MG Oral TabletSCD22e10810-16fb-4c84-bccf-972405b77ef815
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY22e10810-16fb-4c84-bccf-972405b77ef815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5457-250090545702100 TABLET in 1 BOTTLE (50090-5457-2) 100 tablet2021-01-290000-00-00NoNoCurrent
50090-5457-95009054570936 TABLET in 1 BOTTLE (50090-5457-9) 36 tablet2021-01-290000-00-00NoNoCurrent