FDA.reportPublic FDA data

Methotrexate

Product NDC
71335-1118
11-digit product format
713351118
Labeler code
71335
Product ID
71335-1118_5f07ff4f-6a15-4a3e-a478-e6892306fd24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA081235
Marketing category
ANDA
Marketing start
1992-05-18
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
2026-12-31
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
71335-1118-12024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-12024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-22024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-22024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-32024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-32024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-42024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-42024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-52024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-52024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-62024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-62024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-72024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-72024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-82024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-82024-05-17C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-12024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-12024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-22024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-22024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-32024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-32024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-42024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-42024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-52024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-52024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-62024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-62024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-72024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-72024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-82024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-82024-01-30C16284748780-11030e365-5cfe-111a-e063-dadaa90a10e2These 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
71335-1118-1Methotrexate30 in 1 BOTTLETABLET305
71335-1118-2Methotrexate12 in 1 BOTTLETABLET125
71335-1118-3Methotrexate20 in 1 BOTTLETABLET205
71335-1118-4Methotrexate100 in 1 BOTTLETABLET1005
71335-1118-5Methotrexate36 in 1 BOTTLETABLET365
71335-1118-6Methotrexate24 in 1 BOTTLETABLET245
71335-1118-7Methotrexate90 in 1 BOTTLETABLET905
71335-1118-8Methotrexate4 in 1 BOTTLETABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1118METHOTREXATE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20240518_0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSN0b54b5c4-2466-4f85-b9a0-ad93ec4a06a15
105585methotrexate 2.5 MG Oral TabletSCD0b54b5c4-2466-4f85-b9a0-ad93ec4a06a15
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY0b54b5c4-2466-4f85-b9a0-ad93ec4a06a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1118-17133511180130 TABLET in 1 BOTTLE (71335-1118-1) 30 tablet2019-02-250000-00-00NoNoCurrent
71335-1118-27133511180212 TABLET in 1 BOTTLE (71335-1118-2) 12 tablet2024-05-170000-00-00NoNoCurrent
71335-1118-37133511180320 TABLET in 1 BOTTLE (71335-1118-3) 20 tablet2024-05-170000-00-00NoNoCurrent
71335-1118-471335111804100 TABLET in 1 BOTTLE (71335-1118-4) 100 tablet2024-05-170000-00-00NoNoCurrent
71335-1118-57133511180536 TABLET in 1 BOTTLE (71335-1118-5) 36 tablet2024-05-170000-00-00NoNoCurrent
71335-1118-67133511180624 TABLET in 1 BOTTLE (71335-1118-6) 24 tablet2024-05-170000-00-00NoNoCurrent
71335-1118-77133511180790 TABLET in 1 BOTTLE (71335-1118-7) 90 tablet2024-05-170000-00-00NoNoCurrent
71335-1118-8713351118084 TABLET in 1 BOTTLE (71335-1118-8) 4 tablet2024-05-170000-00-00NoNoCurrent