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Ropivacaine Hydrochloride

These highlights do not include all the information needed to use ROPIVACAINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ROPIVACAINE HYDROCHLORIDE INJECTION. ROPIVACAINE HYDROCHLORIDE injection, for epidural, perineural, or infiltration use Initial U.S. Approval: 1996                             Rx Only

Approved
Approval ID

a9010ea8-0923-44e4-a7c7-7d65d37d06db

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 4, 2024

Manufacturers
FDA

Caplin Steriles Limited

DUNS: 650744670

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 Code65145-109
Application NumberANDA212808
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateJanuary 4, 2024
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
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 Code65145-108
Application NumberANDA212808
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateJanuary 4, 2024
FDA Product Classification

INGREDIENTS (5)

ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Ropivacaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65145-110
Application NumberANDA212808
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL
Effective DateJanuary 4, 2024
FDA Product Classification

INGREDIENTS (5)

HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Ropivacaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65145-107
Application NumberANDA212808
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateJanuary 4, 2024
FDA Product Classification

INGREDIENTS (5)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Ropivacaine Hydrochloride - FDA Drug Approval Details