FDA.reportPublic FDA data

METHOTREXATE

Product NDC
62332-730
11-digit product format
623320730
Labeler code
62332
Product ID
62332-730_f8955339-3c07-40ab-a866-ac75398ad2d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHOTREXATE
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217552
Marketing category
ANDA
Marketing start
2024-06-04
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
2026-12-31

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
62332-730-31METHOTREXATE100 in 1 BOTTLETABLET1003
62332-730-36METHOTREXATE36 in 1 BOTTLETABLET363

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-730-31EA - Each62332-73018ea0987-25dc-41e0-9b30-5db177ade18112024-09-09
62332-730-36EA - Each62332-7306c601291-177f-4cc6-aa0e-577f9e1635f912024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-730METHOTREXATE TABLET [ALEMBIC PHARMACEUTICALS INC.]3Current NDC, 2 package rows20240607_04a95db9-a124-4b97-bd71-1c37a6b3b0c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSN4a04756f-e1c9-4d1e-b309-7be31c9176d6101
105585methotrexate 2.5 MG Oral TabletSCD4a04756f-e1c9-4d1e-b309-7be31c9176d6101
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY4a04756f-e1c9-4d1e-b309-7be31c9176d6101
105585methotrexate 2.5 MG Oral TabletPSN04a95db9-a124-4b97-bd71-1c37a6b3b0c83
105585methotrexate 2.5 MG Oral TabletSCD04a95db9-a124-4b97-bd71-1c37a6b3b0c83
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY04a95db9-a124-4b97-bd71-1c37a6b3b0c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-730-3162332073031100 TABLET in 1 BOTTLE (62332-730-31) 100 tablet2024-06-04NoNoHistorical
62332-730-366233207303636 TABLET in 1 BOTTLE (62332-730-36) 36 tablet2024-06-04NoNoHistorical