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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

4a684b13-669d-4721-8ed4-30cc7762b0b8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 25, 2023

Manufacturers
FDA

Alembic Pharmaceuticals Inc.

DUNS: 079288842

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Treprostinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-515
Application NumberANDA211574
Product Classification
M
Marketing Category
C73584
G
Generic Name
Treprostinil
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJuly 5, 2019
FDA Product Classification

INGREDIENTS (7)

TREPROSTINILActive
Quantity: 50 mg in 20 mL
Code: RUM6K67ESG
Classification: ACTIB
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Treprostinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-514
Application NumberANDA211574
Product Classification
M
Marketing Category
C73584
G
Generic Name
Treprostinil
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJuly 5, 2019
FDA Product Classification

INGREDIENTS (7)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
TREPROSTINILActive
Quantity: 20 mg in 20 mL
Code: RUM6K67ESG
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Treprostinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-516
Application NumberANDA211574
Product Classification
M
Marketing Category
C73584
G
Generic Name
Treprostinil
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJuly 5, 2019
FDA Product Classification

INGREDIENTS (7)

TREPROSTINILActive
Quantity: 100 mg in 20 mL
Code: RUM6K67ESG
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Treprostinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-517
Application NumberANDA211574
Product Classification
M
Marketing Category
C73584
G
Generic Name
Treprostinil
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJuly 5, 2019
FDA Product Classification

INGREDIENTS (7)

TREPROSTINILActive
Quantity: 200 mg in 20 mL
Code: RUM6K67ESG
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT

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Treprostinil - FDA Drug Approval Details