FDA.reportPublic FDA data

Rasuvo

Product NDC
59137-535
11-digit product format
591370535
Labeler code
59137
Product ID
59137-535_29d04017-dd64-4dea-a064-7b3b0805f423
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methotrexate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Medexus Pharma Inc.
Application
NDA205776
Marketing category
NDA
Marketing start
2014-07-10
Substance
METHOTREXATE SODIUM
Active strength
22.5 mg/.45mL
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
Rasuvo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE SODIUM22.5 mg/.45mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3IG1E710ZN
Rxcui1441416, 1544378, 1544383, 1544385, 1544386, 1544387, 1544388, 1544389, 1544390, 1544394, 1544395, 1544396, 1544397, 1544398, 1544401, 1544402, 1544403, 1544404

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
59137-535-00Rasuvo0.45 mL in 1 PACKAGEINJECTION, SOLUTION0.4510
59137-535-01Rasuvo1 in 1 CARTONINJECTION, SOLUTION110
59137-535-04Rasuvo4 in 1 CARTONINJECTION, SOLUTION410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59137-535-00ML - Milliliter59137-5359d4ea404-ecc4-47bf-bff3-74cc7807338f12017-03-06
59137-535-01ML - Milliliter59137-53579974404-4642-47e2-b075-78de689ed52e12014-09-03
59137-535-04ML - Milliliter59137-535dd6b5b0b-5c4e-4db4-998c-0764fdf7596e12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
methotrexate sodiumACTIVE INGREDIENT3IG1E710ZNRASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]3
methotrexateACTIVE MOIETYYL5FZ2Y5U1RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]3
hydrochloric acidINACTIVE INGREDIENTQTT17582CBRASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XRASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32IRASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]3
waterINACTIVE INGREDIENT059QF0KO0RRASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59137-535RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDEXUS PHARMA INC.]9Current NDC, Legacy NDC, 3 package rows20241211_d0075461-0e7e-4967-9c9b-d6440e912c0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544378methotrexate 10 MG in 0.2 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544385methotrexate 12.5 MG in 0.25 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544387methotrexate 15 MG in 0.3 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544389methotrexate 17.5 MG in 0.35 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1441416methotrexate 20 MG in 0.4 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544395methotrexate 22.5 MG in 0.45 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544397methotrexate 25 MG in 0.5 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544401methotrexate 30 MG in 0.6 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544403methotrexate 7.5 MG in 0.15 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544383Rasuvo 10 MG in 0.2 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544386Rasuvo 12.5 MG in 0.25 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544388Rasuvo 15 MG in 0.3 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544390Rasuvo 17.5 MG in 0.35 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544394Rasuvo 20 MG in 0.4 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544396Rasuvo 22.5 MG in 0.45 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544398Rasuvo 25 MG in 0.5 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544402Rasuvo 30 MG in 0.6 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544404Rasuvo 7.5 MG in 0.15 ML Auto-InjectorPSNd0075461-0e7e-4967-9c9b-d6440e912c0e10
15444040.15 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443830.2 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443860.25 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443880.3 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443900.35 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443940.4 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443960.45 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443980.5 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15444020.6 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]SBDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15444030.15 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443780.2 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443850.25 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443870.3 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443890.35 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
14414160.4 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443950.45 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443970.5 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15444010.6 ML methotrexate 50 MG/ML Auto-InjectorSCDd0075461-0e7e-4967-9c9b-d6440e912c0e10
15444040.15 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443830.2 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443860.25 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443880.3 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443900.35 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443940.4 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443960.45 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
15443980.5 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
15444020.6 ML Rasuvo 50 MG/ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544378methotrexate (as methotrexate sodium) 10 MG per 0.2 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544385methotrexate (as methotrexate sodium) 12.5 MG per 0.25 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544387methotrexate (as methotrexate sodium) 15 MG per 0.3 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544389methotrexate (as methotrexate sodium) 17.5 MG per 0.35 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1441416methotrexate (as methotrexate sodium) 50 MG/ML 0.4 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544395methotrexate (as methotrexate sodium) 50 MG/ML in 0.45 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544397methotrexate (as methotrexate sodium) 50 MG/ML in 0.5 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544401methotrexate (as methotrexate sodium) 50 MG/ML in 0.6 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544403methotrexate (as methotrexate sodium) 7.5 MG per 0.15 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544378methotrexate 10 MG per 0.2 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544385methotrexate 12.5 MG per 0.25 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544387methotrexate 15 MG per 0.3 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544389methotrexate 17.5 MG per 0.35 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1441416methotrexate 20 MG per 0.4 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544395methotrexate 22.5 MG per 0.45 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544397methotrexate 25 MG per 0.5 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544401methotrexate 30 MG per 0.6 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544403methotrexate 7.5 MG per 0.15 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544404Rasuvo (as methotrexate sodium) 50 MG/ML in 0.15 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544383Rasuvo (as methotrexate sodium) 50 MG/ML in 0.2 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544386Rasuvo (as methotrexate sodium) 50 MG/ML in 0.25 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544388Rasuvo (as methotrexate sodium) 50 MG/ML in 0.3 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544390Rasuvo (as methotrexate sodium) 50 MG/ML in 0.35 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544394Rasuvo (as methotrexate sodium) 50 MG/ML in 0.4 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544396Rasuvo (as methotrexate sodium) 50 MG/ML in 0.45 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544398Rasuvo (as methotrexate sodium) 50 MG/ML in 0.5 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544402Rasuvo (as methotrexate sodium) 50 MG/ML in 0.6 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544383Rasuvo 10 MG per 0.2 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544386Rasuvo 12.5 MG per 0.25 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544388Rasuvo 15 MG per 0.3 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544390Rasuvo 17.5 MG per 0.35 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544394Rasuvo 20 MG per 0.4 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544396Rasuvo 22.5 MG per 0.45 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544398Rasuvo 25 MG per 0.5 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10
1544402Rasuvo 30 MG per 0.6 ML Auto-InjectorSYd0075461-0e7e-4967-9c9b-d6440e912c0e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59137-535-00591370535000.45 mL in 1 PACKAGE0.45 mlHistorical
59137-535-01591370535011 PACKAGE in 1 CARTON (59137-535-01) / .45 mL in 1 PACKAGE (59137-535-00) 1 package2014-07-100000-00-00NoNoCurrent
59137-535-04591370535044 PACKAGE in 1 CARTON (59137-535-04) / .45 mL in 1 PACKAGE (59137-535-00) 4 package2014-07-100000-00-00NoNoCurrent