Methotrexate

Product NDC
70771-1058
11-digit product format
707711058
Labeler code
70771
Product ID
70771-1058_ae399908-cfb6-44dc-83da-8981f5dabbb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207812
Marketing category
ANDA
Marketing start
2017-02-09
Substance
METHOTREXATE
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
METHOTREXATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYL5FZ2Y5U1
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
70771-1058-0Methotrexate1000 in 1 BOTTLETABLET10008
70771-1058-1Methotrexate100 in 1 BOTTLETABLET1008
70771-1058-2Methotrexate1 in 1 BLISTER PACKTABLET18
70771-1058-3Methotrexate36 in 1 BOTTLETABLET368
70771-1058-5Methotrexate500 in 1 BOTTLETABLET5008
70771-1058-7Methotrexate100 in 1 CARTONTABLET1008
70771-1058-9Methotrexate90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1058METHOTREXATE TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20241207_59ea7b32-2b6d-4197-92c3-015936f04ebe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSN59ea7b32-2b6d-4197-92c3-015936f04ebe8
105585methotrexate 2.5 MG Oral TabletSCD59ea7b32-2b6d-4197-92c3-015936f04ebe8
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY59ea7b32-2b6d-4197-92c3-015936f04ebe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1058-0707711058001000 TABLET in 1 BOTTLE (70771-1058-0) 1000 tablet2017-02-090000-00-00NoNoCurrent
70771-1058-170771105801100 TABLET in 1 BOTTLE (70771-1058-1) 100 tablet2017-02-090000-00-00NoNoCurrent
70771-1058-2707711058021 in 1 BLISTER PACKHistorical
70771-1058-37077110580336 TABLET in 1 BOTTLE (70771-1058-3) 36 tablet2017-02-090000-00-00NoNoCurrent
70771-1058-570771105805500 TABLET in 1 BOTTLE (70771-1058-5) 500 tablet2017-02-090000-00-00NoNoCurrent
70771-1058-770771105807100 BLISTER PACK in 1 CARTON (70771-1058-7) / 1 TABLET in 1 BLISTER PACK (70771-1058-2) 100 blister pack2017-02-090000-00-00NoNoCurrent
70771-1058-97077110580990 TABLET in 1 BOTTLE (70771-1058-9) 90 tablet2017-02-090000-00-00NoNoCurrent