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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54436-022
Application NumberNDA204824
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54436-012
Application NumberNDA204824
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54436-075
Application NumberNDA204824
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54436-017
Application NumberNDA204824
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54436-010
Application NumberNDA204824
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54436-025
Application NumberNDA204824
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54436-020
Application NumberNDA204824
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54436-015
Application NumberNDA204824
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 21, 2017
FDA Product Classification

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

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Otrexup - FDA Drug Approval Details