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 use Initial U.S. Approval: 1996                                               Rx Only

Approved
Approval ID

643c1729-096e-459c-80c1-78b78e698da6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 22, 2022

Manufacturers
FDA

Gland Pharma Limited

DUNS: 918601238

Products 2

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 Code68083-263
Application NumberANDA210102
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, EPIDURAL
Effective DateAugust 22, 2022
FDA Product Classification

INGREDIENTS (5)

ROPIVACAINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Ropivacaine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68083-262
Application NumberANDA210102
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ropivacaine hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, EPIDURAL
Effective DateAugust 22, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: V910P86109
Classification: ACTIB

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Ropivacaine hydrochloride - FDA Drug Approval Details