FDA.reportPublic FDA data

Methotrexate

Product NDC
0378-0014
11-digit product format
003780014
Labeler code
0378
Product ID
0378-0014_01ad6cb9-5879-4c06-801b-0de84eebaae7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA081235
Marketing category
ANDA
Marketing start
1992-05-18
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
0378-0014-01Methotrexate100 in 1 BOTTLE, PLASTICTABLET10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0014-01EA - Each0378-0014794f099f-9ea2-4efa-aef8-af2ca08520af12012-07-24
0378-0014-50EA - Each0378-0014e111a7f2-7632-41ca-a9dd-5348a41cb72f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOTREXATEACTIVE INGREDIENTYL5FZ2Y5U1METHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1METHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM CARBONATE MONOHYDRATEINACTIVE INGREDIENT2A1Q1Q3557METHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]6
METHOTREXATEACTIVE INGREDIENTYL5FZ2Y5U1METHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1METHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
SODIUM CARBONATE MONOHYDRATEINACTIVE INGREDIENT2A1Q1Q3557METHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0014METHOTREXATE TABLET [MYLAN PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 1 package rows20240724_70c09984-2b36-424f-8b27-3fd0cd4e833d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSN8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a20
105585methotrexate 2.5 MG Oral TabletSCD8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a20
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a20
105585methotrexate 2.5 MG Oral TabletPSN70c09984-2b36-424f-8b27-3fd0cd4e833d19
105585methotrexate 2.5 MG Oral TabletSCD70c09984-2b36-424f-8b27-3fd0cd4e833d19
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY70c09984-2b36-424f-8b27-3fd0cd4e833d19
105585methotrexate 2.5 MG Oral TabletPSN6f14ced9-c16b-905a-e053-2a91aa0a031e10
105585methotrexate 2.5 MG Oral TabletSCD6f14ced9-c16b-905a-e053-2a91aa0a031e10
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY6f14ced9-c16b-905a-e053-2a91aa0a031e10
105585methotrexate 2.5 MG Oral TabletPSN0b54b5c4-2466-4f85-b9a0-ad93ec4a06a15
105585methotrexate 2.5 MG Oral TabletSCD0b54b5c4-2466-4f85-b9a0-ad93ec4a06a15
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY0b54b5c4-2466-4f85-b9a0-ad93ec4a06a15
105585methotrexate 2.5 MG Oral TabletPSNf177e6fa-c482-432d-8208-937468ab3f102
105585methotrexate 2.5 MG Oral TabletSCDf177e6fa-c482-432d-8208-937468ab3f102
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSYf177e6fa-c482-432d-8208-937468ab3f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0014-0100378001401100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01) 100 tablet1992-05-180000-00-00NoNoCurrent