Rasuvo
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: 1953
Approved
Approval ID
d0075461-0e7e-4967-9c9b-d6440e912c0e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2023
Manufacturers
FDA
Medexus Pharma Inc.
DUNS: 078811131
Products 9
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 Code59137-530
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
methotrexate sodiumActive
Quantity: 20 mg in 0.4 mL
Code: 3IG1E710ZN
Classification: ACTIM
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59137-515
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
methotrexate sodiumActive
Quantity: 12.5 mg in 0.25 mL
Code: 3IG1E710ZN
Classification: ACTIM
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59137-535
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
methotrexate sodiumActive
Quantity: 22.5 mg in 0.45 mL
Code: 3IG1E710ZN
Classification: ACTIM
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59137-525
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
methotrexate sodiumActive
Quantity: 17.5 mg in 0.35 mL
Code: 3IG1E710ZN
Classification: ACTIM
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59137-550
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
methotrexate sodiumActive
Quantity: 30 mg in 0.6 mL
Code: 3IG1E710ZN
Classification: ACTIM
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59137-520
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
methotrexate sodiumActive
Quantity: 15 mg in 0.3 mL
Code: 3IG1E710ZN
Classification: ACTIM
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59137-510
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
methotrexate sodiumActive
Quantity: 10 mg in 0.2 mL
Code: 3IG1E710ZN
Classification: ACTIM
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59137-540
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
methotrexate sodiumActive
Quantity: 25 mg in 0.5 mL
Code: 3IG1E710ZN
Classification: ACTIM
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59137-505
Application NumberNDA205776
Product Classification
M
Marketing Category
C73594
G
Generic Name
methotrexate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (5)
methotrexate sodiumActive
Quantity: 7.5 mg in 0.15 mL
Code: 3IG1E710ZN
Classification: ACTIM
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT