Methotrexate

Product NDC
71335-0782
11-digit product format
713350782
Labeler code
71335
Product ID
71335-0782_c5595381-c3bc-43a4-9c65-0b68b454a891
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0782-1Methotrexate30 in 1 BOTTLETABLET309
71335-0782-2Methotrexate12 in 1 BOTTLETABLET129
71335-0782-3Methotrexate20 in 1 BOTTLETABLET209
71335-0782-4Methotrexate100 in 1 BOTTLETABLET1009
71335-0782-5Methotrexate36 in 1 BOTTLETABLET369
71335-0782-6Methotrexate24 in 1 BOTTLETABLET249
71335-0782-7Methotrexate90 in 1 BOTTLETABLET909
71335-0782-8Methotrexate4 in 1 BOTTLETABLET49

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0782METHOTREXATE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 8 package rows20241004_e6611304-4622-4b2e-9b94-57fbad023ae2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSNe6611304-4622-4b2e-9b94-57fbad023ae29
105585methotrexate 2.5 MG Oral TabletSCDe6611304-4622-4b2e-9b94-57fbad023ae29
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSYe6611304-4622-4b2e-9b94-57fbad023ae29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0782-17133507820130 TABLET in 1 BOTTLE (71335-0782-1) 30 tablet2019-02-250000-00-00NoNoCurrent
71335-0782-27133507820212 TABLET in 1 BOTTLE (71335-0782-2) 12 tablet2021-04-090000-00-00NoNoCurrent
71335-0782-37133507820320 TABLET in 1 BOTTLE (71335-0782-3) 20 tablet2021-04-090000-00-00NoNoCurrent
71335-0782-471335078204100 TABLET in 1 BOTTLE (71335-0782-4) 100 tablet2018-04-190000-00-00NoNoCurrent
71335-0782-57133507820536 TABLET in 1 BOTTLE (71335-0782-5) 36 tablet2021-04-090000-00-00NoNoCurrent
71335-0782-67133507820624 TABLET in 1 BOTTLE (71335-0782-6) 24 tablet2021-04-090000-00-00NoNoCurrent
71335-0782-77133507820790 TABLET in 1 BOTTLE (71335-0782-7) 90 tablet2021-04-090000-00-00NoNoCurrent
71335-0782-8713350782084 TABLET in 1 BOTTLE (71335-0782-8) 4 tablet2021-04-090000-00-00NoNoCurrent