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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 useInitial U.S. Approval: May 2002

Approved
Approval ID

473297ca-a872-4052-a053-87dc8f0d3c13

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 6, 2023

Manufacturers
FDA

Sandoz Inc

DUNS: 005387188

Products 5

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

water solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0781-6021
Application NumberANDA203649
Product Classification
M
Marketing Category
C73584
G
Generic Name
water solution
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateOctober 3, 2018
FDA Product Classification

INGREDIENTS (4)

WATERActive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: ACTIB
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

treprostinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0781-3420
Application NumberANDA203649
Product Classification
M
Marketing Category
C73584
G
Generic Name
treprostinil
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateOctober 3, 2018
FDA Product Classification

INGREDIENTS (6)

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

treprostinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0781-3425
Application NumberANDA203649
Product Classification
M
Marketing Category
C73584
G
Generic Name
treprostinil
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateOctober 3, 2018
FDA Product Classification

INGREDIENTS (6)

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

treprostinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0781-3430
Application NumberANDA203649
Product Classification
M
Marketing Category
C73584
G
Generic Name
treprostinil
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateOctober 3, 2018
FDA Product Classification

INGREDIENTS (6)

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

treprostinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0781-3427
Application NumberANDA203649
Product Classification
M
Marketing Category
C73584
G
Generic Name
treprostinil
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateOctober 3, 2018
FDA Product Classification

INGREDIENTS (6)

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

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