FDA.reportPublic FDA data

Methotrexate

Product NDC
16729-486
11-digit product format
167290486
Labeler code
16729
Product ID
16729-486_424d715c-25c3-6376-e063-6294a90a2ef4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA213343
Marketing category
ANDA
Marketing start
2020-08-24
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-486-01Methotrexate100 in 1 BOTTLETABLET1008
16729-486-36Methotrexate36 in 1 BOTTLETABLET368

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-486METHOTREXATE TABLET [ACCORD HEALTHCARE INC.]6Current NDC, Legacy NDC, 2 package rows20231203_874c7f43-a3be-4236-89cc-24c44e3c5813.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSN4741a44f-0d0b-4380-84f6-231a8d1560fb105
105585methotrexate 2.5 MG Oral TabletSCD4741a44f-0d0b-4380-84f6-231a8d1560fb105
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY4741a44f-0d0b-4380-84f6-231a8d1560fb105
105585methotrexate 2.5 MG Oral TabletPSN874c7f43-a3be-4236-89cc-24c44e3c58138
105585methotrexate 2.5 MG Oral TabletSCD874c7f43-a3be-4236-89cc-24c44e3c58138
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY874c7f43-a3be-4236-89cc-24c44e3c58138
105585methotrexate 2.5 MG Oral TabletPSN2f20d43e-a4b3-a839-e063-6394a90ace381
105585methotrexate 2.5 MG Oral TabletPSN50b2cfc7-dfe4-4406-e063-6294a90a25271
105585methotrexate 2.5 MG Oral TabletPSNa76808f0-38a7-4b54-a4fb-3584f9058ae51
105585methotrexate 2.5 MG Oral TabletSCD2f20d43e-a4b3-a839-e063-6394a90ace381
105585methotrexate 2.5 MG Oral TabletSCD50b2cfc7-dfe4-4406-e063-6294a90a25271
105585methotrexate 2.5 MG Oral TabletSCDa76808f0-38a7-4b54-a4fb-3584f9058ae51
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY2f20d43e-a4b3-a839-e063-6394a90ace381
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY50b2cfc7-dfe4-4406-e063-6294a90a25271
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSYa76808f0-38a7-4b54-a4fb-3584f9058ae51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-486-0116729048601100 TABLET in 1 BOTTLE (16729-486-01) 100 tablet2020-08-240000-00-00NoNoCurrent
16729-486-361672904863636 in 1 BOTTLEHistorical