Ropivacaine Hydrochloride
These highlights do not include all the information needed to use Ropivacaine Hydrochloride Injection, USP safely and effectively. See full prescribing information for Ropivacaine Hydrochloride Injection, USP Ropivacaine hydrochloride injection, for epidural, perineural, or infiltration useInitial U.S. Approval: 1996 Rx Only
Approved
Approval ID
ffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe64
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2022
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-061
Application NumberANDA207636
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateJuly 12, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-062
Application NumberANDA207636
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateJuly 12, 2022
FDA Product Classification
INGREDIENTS (5)
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-067
Application NumberANDA207636
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL
Effective DateJuly 12, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V910P86109
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-063
Application NumberANDA207636
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateJuly 12, 2022
FDA Product Classification
INGREDIENTS (5)
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-066
Application NumberANDA207636
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL
Effective DateJuly 12, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V910P86109
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-064
Application NumberANDA207636
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateJuly 12, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-065
Application NumberANDA207636
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, PERINEURAL
Effective DateJuly 12, 2022
FDA Product Classification
INGREDIENTS (5)
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 7.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT