Treprostinil
These highlights do not include all the information needed to use TREPROSTINIL INJECTION safely and effectively. See full prescribing information for TREPROSTINIL INJECTION. TREPROSTINIL Injection, for subcutaneous or intravenous use Initial U.S. Approval: May 2002
Approved
Approval ID
4b2ce4aa-4302-49db-9456-c8cf0e034968
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2022
Manufacturers
FDA
Teva Parenteral Medicines, Inc.
DUNS: 794362533
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Treprostinil
PRODUCT DETAILS
NDC Product Code0703-0686
Application NumberANDA206648
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateMay 1, 2022
Generic NameTreprostinil
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TREPROSTINILActive
Quantity: 100 mg in 20 mL
Code: RUM6K67ESG
Classification: ACTIB
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Treprostinil
PRODUCT DETAILS
NDC Product Code0703-0666
Application NumberANDA206648
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateMay 1, 2022
Generic NameTreprostinil
INGREDIENTS (7)
TREPROSTINILActive
Quantity: 20 mg in 20 mL
Code: RUM6K67ESG
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Treprostinil
PRODUCT DETAILS
NDC Product Code0703-0676
Application NumberANDA206648
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateMay 1, 2022
Generic NameTreprostinil
INGREDIENTS (7)
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
TREPROSTINILActive
Quantity: 50 mg in 20 mL
Code: RUM6K67ESG
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Treprostinil
PRODUCT DETAILS
NDC Product Code0703-0696
Application NumberANDA206648
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateMay 1, 2022
Generic NameTreprostinil
INGREDIENTS (7)
TREPROSTINILActive
Quantity: 200 mg in 20 mL
Code: RUM6K67ESG
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT