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 Rx Only
Approved
Approval ID
35743510-728d-407b-b501-cf019665cd35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
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 Code0143-9266
Application NumberANDA214074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL
Effective DateMarch 23, 2023
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 7.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9263
Application NumberANDA214074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION
Effective DateMarch 23, 2023
FDA Product Classification
INGREDIENTS (6)
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9265
Application NumberANDA214074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL
Effective DateMarch 23, 2023
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
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
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM
Ropivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9264
Application NumberANDA214074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION
Effective DateMarch 23, 2023
FDA Product Classification
INGREDIENTS (6)
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM