FDA.reportPublic FDA data

Otrexup

Product NDC
54436-017
11-digit product format
544360017
Labeler code
54436
Product ID
54436-017_2d07eb50-d314-a6a0-e063-6394a90ac970
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methotrexate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Antares Pharma, Inc.
Application
NDA204824
Marketing category
NDA
Marketing start
2013-10-11
Marketing end
2027-04-30
Substance
METHOTREXATE
Active strength
17.5 mg/.4mL
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Otrexup

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE17.5 mg/.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYL5FZ2Y5U1
Rxcui1441402, 1441407, 1441411, 1441413, 1441416, 1441418, 1441422, 1441424, 1594757, 1594759, 1747179, 1747181, 1747185, 1747187, 1747192, 1747194

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
54436-017-01Otrexup1 in 1 CARTONINJECTION, SOLUTION115
54436-017-01Otrexup0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.415
54436-017-02Otrexup0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.415
54436-017-03Otrexup1 in 1 CARTONINJECTION, SOLUTION115
54436-017-03Otrexup0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.415
54436-017-04Otrexup4 in 1 CARTONINJECTION, SOLUTION415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54436-017-02ML - Milliliter54436-017706d6606-1f09-4d54-a454-3055eb7eb07612016-05-16
54436-017-04ML - Milliliter54436-01701a4fa22-d306-400a-adfa-18492ddc4d6f12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOTREXATEACTIVE INGREDIENTYL5FZ2Y5U1OTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]3
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1OTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0ROTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54436-017OTREXUP (METHOTREXATE) INJECTION, SOLUTION [ANTARES PHARMA, INC.]15Current NDC, Legacy NDC, 6 package rows20250202_9ab8ce16-f7de-41d4-a4c8-1c742621b6d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441402methotrexate 10 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747179methotrexate 12.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441411methotrexate 15 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747185methotrexate 17.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441416methotrexate 20 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747192methotrexate 22.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441422methotrexate 25 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1594757methotrexate 7.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441407Otrexup 10 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747181Otrexup 12.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441413Otrexup 15 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747187Otrexup 17.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441418Otrexup 20 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747194Otrexup 22.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441424Otrexup 25 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1594759Otrexup 7.5 MG in 0.4 ML Auto-InjectorPSN9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
15947590.4 ML methotrexate 18.8 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414070.4 ML methotrexate 25 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471810.4 ML methotrexate 31.3 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414130.4 ML methotrexate 37.5 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471870.4 ML methotrexate 43.8 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414180.4 ML methotrexate 50 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471940.4 ML methotrexate 56.3 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414240.4 ML methotrexate 62.5 MG/ML Auto-Injector [Otrexup]SBD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
15947570.4 ML methotrexate 18.8 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414020.4 ML methotrexate 25 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471790.4 ML methotrexate 31.3 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414110.4 ML methotrexate 37.5 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471850.4 ML methotrexate 43.8 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414160.4 ML methotrexate 50 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471920.4 ML methotrexate 56.3 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414220.4 ML methotrexate 62.5 MG/ML Auto-InjectorSCD9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
15947590.4 ML Otrexup 18.8 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414070.4 ML Otrexup 25 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471810.4 ML Otrexup 31.3 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414130.4 ML Otrexup 37.5 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471870.4 ML Otrexup 43.8 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414180.4 ML Otrexup 50 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
17471940.4 ML Otrexup 56.3 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
14414240.4 ML Otrexup 62.5 MG/ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441416methotrexate (as methotrexate sodium) 50 MG/ML 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441402methotrexate 10 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747179methotrexate 12.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441411methotrexate 15 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747185methotrexate 17.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441416methotrexate 20 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747192methotrexate 22.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441422methotrexate 25 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1594757methotrexate 7.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441407Otrexup 10 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747181Otrexup 12.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441413Otrexup 15 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747187Otrexup 17.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441418Otrexup 20 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1747194Otrexup 22.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441424Otrexup 25 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441407Otrexup 25 MG/ML in 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441413Otrexup 37.5 MG/ML in 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441418Otrexup 50 MG/ML in 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1441424Otrexup 62.5 MG/ML in 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515
1594759Otrexup 7.5 MG per 0.4 ML Auto-InjectorSY9ab8ce16-f7de-41d4-a4c8-1c742621b6d515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54436-017-01544360017011 SYRINGE in 1 CARTON (54436-017-01) / .4 mL in 1 SYRINGE1 syringe2016-03-242027-04-30NoNoCurrent
54436-017-02544360017020.4 mL in 1 SYRINGE0.4 mlHistorical
54436-017-03544360017031 SYRINGE in 1 CARTON (54436-017-03) / .4 mL in 1 SYRINGE1 syringe2016-03-242027-04-30YesNoCurrent
54436-017-04544360017044 SYRINGE in 1 CARTON (54436-017-04) / .4 mL in 1 SYRINGE (54436-017-02) 4 syringe2016-03-242027-04-30NoNoCurrent