FDA.reportPublic FDA data

Methotrexate

Product NDC
68382-775
11-digit product format
683820775
Labeler code
68382
Product ID
68382-775_5d9b7269-19d4-4d2c-b252-f3ff759dffa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
2027-12-31
Current FDA listing
Yes

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
68382-775-01Methotrexate100 in 1 BOTTLETABLET1009
68382-775-05Methotrexate500 in 1 BOTTLETABLET5009
68382-775-10Methotrexate1000 in 1 BOTTLETABLET10009
68382-775-16Methotrexate90 in 1 BOTTLETABLET909
68382-775-60Methotrexate36 in 1 BOTTLETABLET369
68382-775-77Methotrexate100 in 1 CARTONTABLET1009
68382-775-77Methotrexate1 in 1 BLISTER PACKTABLET19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-775-01EA - Each68382-7757bfb7a0d-47b6-45e7-b2d0-d3e250a598c612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-775METHOTREXATE TABLET [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 7 package rows20231110_948e0bab-6524-4b87-9853-1799d4415558.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSN948e0bab-6524-4b87-9853-1799d44155589
105585methotrexate 2.5 MG Oral TabletSCD948e0bab-6524-4b87-9853-1799d44155589
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY948e0bab-6524-4b87-9853-1799d44155589
105585methotrexate 2.5 MG Oral TabletPSN2a6afc4c-819d-4ba9-8040-4504519c116a6
105585methotrexate 2.5 MG Oral TabletSCD2a6afc4c-819d-4ba9-8040-4504519c116a6
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY2a6afc4c-819d-4ba9-8040-4504519c116a6
105585methotrexate 2.5 MG Oral TabletPSN4992fdaa-b880-ee25-e063-6394a90af03b1
105585methotrexate 2.5 MG Oral TabletSCD4992fdaa-b880-ee25-e063-6394a90af03b1
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY4992fdaa-b880-ee25-e063-6394a90af03b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-775-0168382077501100 TABLET in 1 BOTTLE (68382-775-01) 100 tablet2017-02-090000-00-00NoNoCurrent
68382-775-0568382077505500 TABLET in 1 BOTTLE (68382-775-05) 500 tablet2017-02-090000-00-00NoNoCurrent
68382-775-10683820775101000 TABLET in 1 BOTTLE (68382-775-10) 1000 tablet2017-02-090000-00-00NoNoCurrent
68382-775-166838207751690 TABLET in 1 BOTTLE (68382-775-16) 90 tablet2017-02-090000-00-00NoNoCurrent
68382-775-606838207756036 TABLET in 1 BOTTLE (68382-775-60) 36 tablet2017-02-090000-00-00NoNoCurrent
68382-775-7768382077577100 BLISTER PACK in 1 CARTON (68382-775-77) / 1 TABLET in 1 BLISTER PACK100 blister pack2017-02-090000-00-00NoNoCurrent