Ropivacaine Hydrochloride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . use Initial U.S. Approval: 1996
Approved
Approval ID
da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 4
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 Code70121-1735
Application NumberANDA216605
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateOctober 19, 2023
FDA Product Classification
INGREDIENTS (5)
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1733
Application NumberANDA216605
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateOctober 19, 2023
FDA Product Classification
INGREDIENTS (5)
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1734
Application NumberANDA216605
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateOctober 19, 2023
FDA Product Classification
INGREDIENTS (5)
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1732
Application NumberANDA216605
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateOctober 19, 2023
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: V910P86109
Classification: ACTIB