FDA.reportPublic FDA data

Methotrexate Sodium

Product NDC
0054-4550
11-digit product format
000544550
Labeler code
0054
Product ID
0054-4550_e0c12c0f-ae9c-4d79-8c27-b2ce3861f918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040054
Marketing category
ANDA
Marketing start
1994-08-01
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 Sodium
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
0054-4550-15Methotrexate Sodium36 in 1 BOTTLE, PLASTICTABLET3620
0054-4550-25Methotrexate Sodium100 in 1 BOTTLE, PLASTICTABLET10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-4550-15EA - Each0054-455089a0c385-2d27-4ed2-b1e4-1a713fee776e12012-07-24
0054-4550-25EA - Each0054-45504d872ca4-3204-4936-8f24-c70d1bc7743412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOTREXATE SODIUMACTIVE INGREDIENT3IG1E710ZNMETHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]8
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMETHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-4550METHOTREXATE SODIUM TABLET [HIKMA PHARMACEUTICALS USA INC.]17Current NDC, Legacy NDC, 2 package rows20240302_d71b1856-99d8-4a9e-9189-f87b6675f80a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSNd71b1856-99d8-4a9e-9189-f87b6675f80a20
105585methotrexate 2.5 MG Oral TabletSCDd71b1856-99d8-4a9e-9189-f87b6675f80a20
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSYd71b1856-99d8-4a9e-9189-f87b6675f80a20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-4550-150005445501536 TABLET in 1 BOTTLE, PLASTIC (0054-4550-15) 36 tablet1994-08-010000-00-00NoNoCurrent
0054-4550-2500054455025100 TABLET in 1 BOTTLE, PLASTIC (0054-4550-25) 100 tablet1994-08-010000-00-00NoNoCurrent