FDA.reportPublic FDA data

Methotrexate

Product NDC
16729-277
11-digit product format
167290277
Labeler code
16729
Product ID
16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
INJECTION
Route
INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA040716
Marketing category
ANDA
Marketing start
2014-03-07
Substance
METHOTREXATE
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
METHOTREXATE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYL5FZ2Y5U1
Rxcui1655956, 1655959, 1655960

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
16729-277-03Methotrexate1 in 1 CARTONINJECTION16
16729-277-03Methotrexate10 mL in 1 VIALINJECTION106
16729-277-30Methotrexate1 in 1 CARTONINJECTION16
16729-277-30Methotrexate2 mL in 1 VIALINJECTION26
16729-277-35Methotrexate40 mL in 1 VIALINJECTION406
16729-277-35Methotrexate1 in 1 CARTONINJECTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-277-03ML - Milliliter16729-277d5410565-7b82-4c8e-84ea-9bd78573206a12014-04-03
16729-277-30ML - Milliliter16729-2777f4ded3d-08d1-45af-ac05-def9c248147a12014-04-03
16729-277-35ML - Milliliter16729-27780486de1-b61e-4b26-90fd-ebf539e4158312014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOTREXATEACTIVE INGREDIENTYL5FZ2Y5U1METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMETHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-277METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]6Current NDC, Legacy NDC, 6 package rows20250116_dd035a9f-cd40-4314-b9d8-2294b8a924e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655956methotrexate 1 GM in 40 ML InjectionPSNdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655959methotrexate 250 MG in 10 ML InjectionPSNdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655960methotrexate 50 MG in 2 ML InjectionPSNdd035a9f-cd40-4314-b9d8-2294b8a924e26
165595910 ML methotrexate 25 MG/ML InjectionSCDdd035a9f-cd40-4314-b9d8-2294b8a924e26
16559602 ML methotrexate 25 MG/ML InjectionSCDdd035a9f-cd40-4314-b9d8-2294b8a924e26
165595640 ML methotrexate 25 MG/ML InjectionSCDdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655956methotrexate 1 GM per 40 ML InjectionSYdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655959methotrexate 250 MG per 10 ML InjectionSYdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655960methotrexate 50 MG per 2 ML InjectionSYdd035a9f-cd40-4314-b9d8-2294b8a924e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-277-03167290277031 VIAL in 1 CARTON (16729-277-03) / 10 mL in 1 VIAL1 vial2014-03-070000-00-00NoNoCurrent
16729-277-30167290277301 VIAL in 1 CARTON (16729-277-30) / 2 mL in 1 VIAL1 vial2014-03-070000-00-00NoNoCurrent
16729-277-35167290277351 VIAL in 1 CARTON (16729-277-35) / 40 mL in 1 VIAL1 vial2014-03-070000-00-00NoNoCurrent