FDA.reportPublic FDA data

Methotrexate

Product NDC
71335-2221
11-digit product format
713352221
Labeler code
71335
Product ID
71335-2221_5488dfc1-8f40-4f52-ab27-f08e77b8c5c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210454
Marketing category
ANDA
Marketing start
2020-01-30
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

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
71335-2221-1Methotrexate30 in 1 BOTTLETABLET30100
71335-2221-2Methotrexate12 in 1 BOTTLETABLET12100
71335-2221-3Methotrexate20 in 1 BOTTLETABLET20100
71335-2221-4Methotrexate100 in 1 BOTTLETABLET100100
71335-2221-5Methotrexate36 in 1 BOTTLETABLET36100
71335-2221-6Methotrexate24 in 1 BOTTLETABLET24100
71335-2221-7Methotrexate90 in 1 BOTTLETABLET90100
71335-2221-8Methotrexate4 in 1 BOTTLETABLET4100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2221METHOTREXATE TABLET [BRYANT RANCH PREPACK]100Current NDC, 8 package rows20230824_b6e61c50-024a-494f-b04c-100fb371a837.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSNb6e61c50-024a-494f-b04c-100fb371a837100
105585methotrexate 2.5 MG Oral TabletSCDb6e61c50-024a-494f-b04c-100fb371a837100
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSYb6e61c50-024a-494f-b04c-100fb371a837100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2221-17133522210130 TABLET in 1 BOTTLE (71335-2221-1) 30 tablet2023-08-15NoNoCurrent
71335-2221-27133522210212 TABLET in 1 BOTTLE (71335-2221-2) 12 tablet2023-08-15NoNoCurrent
71335-2221-37133522210320 TABLET in 1 BOTTLE (71335-2221-3) 20 tablet2023-08-15NoNoCurrent
71335-2221-471335222104100 TABLET in 1 BOTTLE (71335-2221-4) 100 tablet2023-08-15NoNoCurrent
71335-2221-57133522210536 TABLET in 1 BOTTLE (71335-2221-5) 36 tablet2023-08-15NoNoCurrent
71335-2221-67133522210624 TABLET in 1 BOTTLE (71335-2221-6) 24 tablet2023-08-15NoNoCurrent
71335-2221-77133522210790 TABLET in 1 BOTTLE (71335-2221-7) 90 tablet2023-08-15NoNoCurrent
71335-2221-8713352221084 TABLET in 1 BOTTLE (71335-2221-8) 4 tablet2023-08-15NoNoCurrent