MedPath

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 useInitial U.S. Approval: 1996 Rx Only

Approved
Approval ID

781d4b7f-7556-4695-8d48-7772d7a0d8e9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 28, 2023

Manufacturers
FDA

Baxter Healthcare Corporation

DUNS: 005083209

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 Code43066-019
Application NumberANDA212808
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropivacaine hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateApril 9, 2020
FDA Product Classification

INGREDIENTS (5)

ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
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 Code43066-023
Application NumberANDA212808
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropivacaine hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateApril 9, 2020
FDA Product Classification

INGREDIENTS (5)

ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 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 Code43066-027
Application NumberANDA212808
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropivacaine hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateApril 9, 2020
FDA Product Classification

INGREDIENTS (5)

ROPIVACAINE HYDROCHLORIDEActive
Quantity: 10 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 Code43066-015
Application NumberANDA212808
Product Classification
M
Marketing Category
C73584
G
Generic Name
ropivacaine hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, PERINEURAL
Effective DateApril 9, 2020
FDA Product Classification

INGREDIENTS (5)

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.