FDA.reportPublic FDA data

Methotrexate

Product NDC
0143-9519
11-digit product format
001439519
Labeler code
0143
Product ID
0143-9519_3046ff78-3565-46d1-a88b-283e5ff6e7c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
SOLUTION
Route
INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA089340
Marketing category
ANDA
Marketing start
2017-10-10
Substance
METHOTREXATE
Active strength
25 mg/mL
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
METHOTREXATE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYL5FZ2Y5U1
Rxcui1655959, 1655960, 1655967, 1655968

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
0143-9519-10Methotrexate2 mL in 1 VIALSOLUTION29
0143-9519-10Methotrexate10 in 1 CARTONSOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9519-10ML - Milliliter0143-9519e555883f-5b64-4372-a18d-8e78427128cc12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9519METHOTREXATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20230420_3989d30d-56e5-4e8d-9379-c30fecc894f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655967methotrexate 100 MG in 4 ML InjectionPSN3989d30d-56e5-4e8d-9379-c30fecc894f29
1655968methotrexate 200 MG in 8 ML InjectionPSN3989d30d-56e5-4e8d-9379-c30fecc894f29
1655959methotrexate 250 MG in 10 ML InjectionPSN3989d30d-56e5-4e8d-9379-c30fecc894f29
1655960methotrexate 50 MG in 2 ML InjectionPSN3989d30d-56e5-4e8d-9379-c30fecc894f29
165595910 ML methotrexate 25 MG/ML InjectionSCD3989d30d-56e5-4e8d-9379-c30fecc894f29
16559602 ML methotrexate 25 MG/ML InjectionSCD3989d30d-56e5-4e8d-9379-c30fecc894f29
16559674 ML methotrexate 25 MG/ML InjectionSCD3989d30d-56e5-4e8d-9379-c30fecc894f29
16559688 ML methotrexate 25 MG/ML InjectionSCD3989d30d-56e5-4e8d-9379-c30fecc894f29
1655967methotrexate 100 MG per 4 ML InjectionSY3989d30d-56e5-4e8d-9379-c30fecc894f29
1655968methotrexate 200 MG per 8 ML InjectionSY3989d30d-56e5-4e8d-9379-c30fecc894f29
1655959methotrexate 250 MG per 10 ML InjectionSY3989d30d-56e5-4e8d-9379-c30fecc894f29
1655960methotrexate 50 MG per 2 ML InjectionSY3989d30d-56e5-4e8d-9379-c30fecc894f29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9519-100014395191010 VIAL in 1 CARTON (0143-9519-10) / 2 mL in 1 VIAL10 vial2017-10-100000-00-00NoNoCurrent