FDA.reportPublic FDA data

Methotrexate

Product NDC
61703-161
11-digit product format
617030161
Labeler code
61703
Product ID
61703-161_6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
NDA011719
Marketing category
NDA
Marketing start
2024-11-04
Substance
METHOTREXATE SODIUM
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
METHOTREXATE SODIUM25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3IG1E710ZN
Rxcui1655956, 1946772

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
61703-161-02Methotrexate2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION26
61703-161-05Methotrexate5 in 1 CARTONINJECTION, SOLUTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-161-02ML - Milliliter61703-1611a6e2292-d659-45a6-aa6e-3c609a56cefe12024-12-10
61703-161-05ML - Milliliter61703-16142244746-3c5e-446f-b3a7-39e6182682ed12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61703-161METHOTREXATE INJECTION, SOLUTION [HOSPIRA, INC.]5Current NDC, 2 package rows20241108_bd287e89-32f9-4396-95fa-4b562869f476.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655956methotrexate 1 GM in 40 ML InjectionPSNbd287e89-32f9-4396-95fa-4b562869f4766
1946772methotrexate 25 MG/mL Injectable SolutionPSNbd287e89-32f9-4396-95fa-4b562869f4766
165595640 ML methotrexate 25 MG/ML InjectionSCDbd287e89-32f9-4396-95fa-4b562869f4766
1946772methotrexate 25 MG/ML Injectable SolutionSCDbd287e89-32f9-4396-95fa-4b562869f4766
1946772methotrexate (as methotrexate sodium) 25 MG/ML Injectable SolutionSYbd287e89-32f9-4396-95fa-4b562869f4766
1655956methotrexate 1 GM per 40 ML InjectionSYbd287e89-32f9-4396-95fa-4b562869f4766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61703-161-02617030161022 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
61703-161-05617030161055 VIAL, MULTI-DOSE in 1 CARTON (61703-161-05) / 2 mL in 1 VIAL, MULTI-DOSE (61703-161-02) 2024-11-04NoNoCurrent