FDA.reportPublic FDA data

Methotrexate

Product NDC
59651-182
11-digit product format
596510182
Labeler code
59651
Product ID
59651-182_9fe03573-fff3-4051-8598-8542eee1273f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-182-01Methotrexate100 in 1 BOTTLETABLET1005
59651-182-36Methotrexate36 in 1 BOTTLETABLET365

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-182-01EA - Each59651-18232408738-1d80-4d05-866d-f67d32f2f02312020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-182METHOTREXATE TABLET [AUROBINDO PHARMA LIMITED]3Current NDC, Legacy NDC, 2 package rows20200710_09931d44-a3f8-49dc-a3f2-b527ee4214bf.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
105585methotrexate 2.5 MG Oral TabletPSN09931d44-a3f8-49dc-a3f2-b527ee4214bf5
105585methotrexate 2.5 MG Oral TabletSCD09931d44-a3f8-49dc-a3f2-b527ee4214bf5
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY09931d44-a3f8-49dc-a3f2-b527ee4214bf5
105585methotrexate 2.5 MG Oral TabletPSN2b61822e-b488-5eaf-e063-6394a90a2dcd2
105585methotrexate 2.5 MG Oral TabletSCD2b61822e-b488-5eaf-e063-6394a90a2dcd2
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY2b61822e-b488-5eaf-e063-6394a90a2dcd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-182-0159651018201100 TABLET in 1 BOTTLE (59651-182-01) 100 tablet2020-01-300000-00-00NoNoCurrent
59651-182-365965101823636 TABLET in 1 BOTTLE (59651-182-36) 36 tablet2020-01-300000-00-00NoNoCurrent