Otrexup
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . OTREXUP (methotrexate) injection, for subcutaneous useInitial U.S. Approval: 1953
Approved
Approval ID
9ab8ce16-f7de-41d4-a4c8-1c742621b6d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Antares Pharma, Inc.
DUNS: 085369585
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methotrexate
PRODUCT DETAILS
NDC Product Code54436-022
Application NumberNDA204824
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
Generic Namemethotrexate
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHOTREXATEActive
Quantity: 22.5 mg in 0.4 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
methotrexate
PRODUCT DETAILS
NDC Product Code54436-012
Application NumberNDA204824
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
Generic Namemethotrexate
INGREDIENTS (3)
METHOTREXATEActive
Quantity: 12.5 mg in 0.4 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
methotrexate
PRODUCT DETAILS
NDC Product Code54436-075
Application NumberNDA204824
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
Generic Namemethotrexate
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHOTREXATEActive
Quantity: 7.5 mg in 0.4 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
methotrexate
PRODUCT DETAILS
NDC Product Code54436-017
Application NumberNDA204824
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
Generic Namemethotrexate
INGREDIENTS (3)
METHOTREXATEActive
Quantity: 17.5 mg in 0.4 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
methotrexate
PRODUCT DETAILS
NDC Product Code54436-010
Application NumberNDA204824
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
Generic Namemethotrexate
INGREDIENTS (3)
METHOTREXATEActive
Quantity: 10 mg in 0.4 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
methotrexate
PRODUCT DETAILS
NDC Product Code54436-025
Application NumberNDA204824
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
Generic Namemethotrexate
INGREDIENTS (3)
METHOTREXATEActive
Quantity: 25 mg in 0.4 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
methotrexate
PRODUCT DETAILS
NDC Product Code54436-020
Application NumberNDA204824
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
Generic Namemethotrexate
INGREDIENTS (3)
METHOTREXATEActive
Quantity: 20 mg in 0.4 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
methotrexate
PRODUCT DETAILS
NDC Product Code54436-015
Application NumberNDA204824
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
Generic Namemethotrexate
INGREDIENTS (3)
METHOTREXATEActive
Quantity: 15 mg in 0.4 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT