FDA.reportPublic FDA data

Xatmep

Product NDC
52652-2001
11-digit product format
526522001
Labeler code
52652
Product ID
52652-2001_461e9d94-1451-904d-e063-6294a90a05f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
SOLUTION
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA208400
Marketing category
NDA
Marketing start
2017-05-01
Substance
METHOTREXATE
Active strength
2.5 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
Xatmep
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYL5FZ2Y5U1
Rxcui1921592, 1921598

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
52652-2001-1Xatmep120 mL in 1 BOTTLESOLUTION12012
52652-2001-6Xatmep60 mL in 1 BOTTLESOLUTION6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52652-2001-1ML - Milliliter52652-200181947cdc-1949-45eb-9c27-139d1e2de7c912017-06-15
52652-2001-6ML - Milliliter52652-20019ca24a30-63b6-490f-9a6b-f058e76c9c4612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52652-2001XATMEP (METHOTREXATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20220630_aec9984e-34c5-481b-b6bf-9bb5caf1daf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1921592methotrexate 2.5 MG/mL Oral SolutionPSNaec9984e-34c5-481b-b6bf-9bb5caf1daf812
1921598Xatmep 2.5 MG/mL Oral SolutionPSNaec9984e-34c5-481b-b6bf-9bb5caf1daf812
1921598methotrexate 2.5 MG/ML Oral Solution [Xatmep]SBDaec9984e-34c5-481b-b6bf-9bb5caf1daf812
1921592methotrexate 2.5 MG/ML Oral SolutionSCDaec9984e-34c5-481b-b6bf-9bb5caf1daf812
1921592methotrexate 2.5 MG/ML (methotrexate sodium 2.74 MG/ML) Oral SolutionSYaec9984e-34c5-481b-b6bf-9bb5caf1daf812
1921598methotrexate 2.5 MG/ML (methotrexate sodium 2.74 MG/ML) Oral Solution [Xatmep]SYaec9984e-34c5-481b-b6bf-9bb5caf1daf812
1921598Xatmep 2.5 MG/ML Oral SolutionSYaec9984e-34c5-481b-b6bf-9bb5caf1daf812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52652-2001-152652200101120 mL in 1 BOTTLE (52652-2001-1) 120 ml2017-05-010000-00-00NoNoCurrent
52652-2001-65265220010660 mL in 1 BOTTLE (52652-2001-6) 60 ml2018-08-130000-00-00NoNoCurrent