Methotrexate Auto-Injector

Brand(s)
Otrexup, Rasuvo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Antares Pharma, Inc. (2014-11-03)
Oldest Current Product
2013-10-11
License(s)
NDA
RxNORM
AUTO-INJECTOR\METHOTREXATE
FDAOB
SUBCUTANEOUS\SOLUTION\METHOTREXATE
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\METHOTREXATE
SUBCUTANEOUS\INJECTION, SOLUTION\METHOTREXATE SODIUM
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\METHOTREXATE

product(s) by strength(s)

0.4 ml methotrexate 18.8 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1544360075OtrexupNDAAntares Pharma, Inc.2013-10-11METHOTREXATESUBCUTANEOUSINJECTION, SOLUTIONNDA2048249ab8ce16-f7de-41d4-a4c8-1c742621b6d5

0.4 ml methotrexate 25 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1544360010OtrexupNDAAntares Pharma, Inc.2013-10-11METHOTREXATESUBCUTANEOUSINJECTION, SOLUTIONNDA2048249ab8ce16-f7de-41d4-a4c8-1c742621b6d5

0.4 ml methotrexate 37.5 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1544360015OtrexupNDAAntares Pharma, Inc.2013-10-11METHOTREXATESUBCUTANEOUSINJECTION, SOLUTIONNDA2048249ab8ce16-f7de-41d4-a4c8-1c742621b6d5

0.15 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370505RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.6 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370550RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.35 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370525RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.25 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370515RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.3 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370520RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.2 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370510RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.55 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370545RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.5 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370540RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.45 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370535RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.4 ml methotrexate 50 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591370530RasuvoNDAMedac Pharma, Inc2014-07-10METHOTREXATE SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA205776d0075461-0e7e-4967-9c9b-d6440e912c0e

0.4 ml methotrexate 62.5 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1544360025OtrexupNDAAntares Pharma, Inc.2013-10-11METHOTREXATESUBCUTANEOUSINJECTION, SOLUTIONNDA2048249ab8ce16-f7de-41d4-a4c8-1c742621b6d5

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA204824OTREXUPANTARES PHARMA INC2013-10-11p8562564, SUBSTANCE
p7744582, SUBCUTANEOUS INJECTION OF METHOTREXATE, SUBSTANCE
pRE44847, SUBCUTANEOUS INJECTION OF METHOTREXATE, SUBSTANCE
pRE44846, SUBSTANCE
p7776015, SUBSTANCE
p8021335, SUBSTANCE
p6746429, SUBSTANCE
p8579865, SUBCUTANEOUS INJECTION OF METHOTREXATE, SUBSTANCE
p8480631, SUBCUTANEOUS INJECTION OF METHOTREXATE, SUBSTANCE
p8945063, SUBCUTANEOUS INJECTION OF METHOTREXATE, SUBSTANCE
NDA204824_001, NDA204824_002, NDA204824_003, NDA204824_004, NDA204824_005
2NDA205776RASUVOMEDAC PHARMA INC2014-07-10p8664231, SUBCUTANEOUS INJECTION OF METHOTREXATENDA205776_001, NDA205776_002, NDA205776_003, NDA205776_004, NDA205776_005, NDA205776_006, NDA205776_007, NDA205776_008, NDA205776_009, NDA205776_010

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204824_001RXMETHOTREXATE (10MG/0.4ML)SUBCUTANEOUSSOLUTIONFalse2013-10-11OTREXUP
2NDA204824_002RXMETHOTREXATE (15MG/0.4ML)SUBCUTANEOUSSOLUTIONFalse2013-10-11OTREXUP
3NDA204824_003RXMETHOTREXATE (20MG/0.4ML)SUBCUTANEOUSSOLUTIONFalse2013-10-11OTREXUP
4NDA204824_004RXMETHOTREXATE (25MG/0.4ML)SUBCUTANEOUSSOLUTIONTrue2013-10-11OTREXUP
5NDA204824_005RXMETHOTREXATE (7.5MG/0.4ML)SUBCUTANEOUSSOLUTIONFalse2014-11-07OTREXUP
6NDA205776_001RXMETHOTREXATE (7.5MG/0.15ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
7NDA205776_002RXMETHOTREXATE (10MG/0.20ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
8NDA205776_003RXMETHOTREXATE (12.5MG/0.25ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
9NDA205776_004RXMETHOTREXATE (15MG/0.30ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
10NDA205776_005RXMETHOTREXATE (17.5MG/0.35ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
11NDA205776_006RXMETHOTREXATE (20MG/0.4ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
12NDA205776_007RXMETHOTREXATE (22.5MG/0.45ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
13NDA205776_008RXMETHOTREXATE (25MG/0.5ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
14NDA205776_009RXMETHOTREXATE (27.5MG/0.55ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO
15NDA205776_010RXMETHOTREXATE (30MG/0.6ML)SUBCUTANEOUSSOLUTIONFalse2014-07-10RASUVO

patent(s)

#idexpiration dateapplication(s)
1p6746429 (view patent)2020-04-12NDA204824
2p7744582 (view patent)2019-08-10NDA204824
3p7776015 (view patent)2019-08-10NDA204824
4p8021335 (view patent)2026-10-04NDA204824
5p8480631 (view patent)2030-03-19NDA204824
6p8562564 (view patent)2026-01-24NDA204824
7p8579865 (view patent)2030-03-19NDA204824
8p8664231 (view patent)2029-06-01NDA205776
9p8945063 (view patent)2030-03-19NDA204824
10pRE44846 (view patent)2019-08-10NDA204824
11pRE44847 (view patent)2019-08-10NDA204824

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19ab8ce16-f7de-41d4-a4c8-1c742621b6d5 (view SPL)These highlights do not include all the information needed to use OTREXUP safely and effectively. See full prescribing information for OTREXUP. OTREXUP (methotrexate) injection, for subcutaneous useInitial U.S. Approval: 1953prescriptionHuman PrescriptionAntares Pharma, Inc.MANUFACTURE, PACK, analysis2014-11-033544360010, 544360015, 544360025, 544360075, 544360020
2d0075461-0e7e-4967-9c9b-d6440e912c0e (view SPL)These highlights do not include all the information needed to use RASUVO safely and effectively. See full prescribing information for RASUVO. RASUVO (methotrexate) injection, for subcutaneous use Initial U.S. Approval: 1953prescriptionHuman PrescriptionMedac Pharma, Inc2015-02-203591370505, 591370510, 591370515, 591370520, 591370525, 591370530, 591370535, 591370540, 591370545, 591370550

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII