Vasostrict
These highlights do not include all the information needed to use VASOSTRICT safely and effectively. See full prescribing information for VASOSTRICT. VASOSTRICT (vasopressin injection) for intravenous useVASOSTRICT (vasopressin in dextrose injection) for intravenous useInitial U.S. Approval: 2014
Approved
Approval ID
b1147beb-743e-4c62-8927-91192447f8b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vasopressin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-190
Application NumberNDA204485
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vasopressin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (6)
CHLOROBUTANOLInactive
Quantity: 5 mg in 1 mL
Code: HM4YQM8WRC
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM ACETATEInactive
Quantity: 1.36 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
VASOPRESSIN, UNSPECIFIEDActive
Quantity: 20 [USP'U] in 1 mL
Code: Y87Y826H08
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Vasopressin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-237
Application NumberNDA204485
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vasopressin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (7)
VASOPRESSIN, UNSPECIFIEDActive
Quantity: 0.2 [USP'U] in 1 mL
Code: Y87Y826H08
Classification: ACTIB
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.0546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.012 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Vasopressin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-219
Application NumberNDA204485
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vasopressin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (7)
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
VASOPRESSIN, UNSPECIFIEDActive
Quantity: 0.4 [USP'U] in 1 mL
Code: Y87Y826H08
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.0546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.012 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Vasopressin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-220
Application NumberNDA204485
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vasopressin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
VASOPRESSIN, UNSPECIFIEDActive
Quantity: 0.6 [USP'U] in 1 mL
Code: Y87Y826H08
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 0.0546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.012 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Vasopressin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-164
Application NumberNDA204485
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vasopressin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
VASOPRESSIN, UNSPECIFIEDActive
Quantity: 20 [USP'U] in 1 mL
Code: Y87Y826H08
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 1.36 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Vasopressin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-268
Application NumberNDA204485
Product Classification
M
Marketing Category
C73594
G
Generic Name
Vasopressin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.012 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
VASOPRESSIN, UNSPECIFIEDActive
Quantity: 1 [USP'U] in 1 mL
Code: Y87Y826H08
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 0.0546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT