NAROPIN
Naropin®(ropivacaine HCl Injection, USP)Rx only
Approved
Approval ID
096c2693-8488-48c2-88ee-bf3df95c3f4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2022
Manufacturers
FDA
General Injectables & Vaccines, Inc
DUNS: 108250663
Products 1
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 Code52584-286
Application NumberNDA020533
Product Classification
M
Marketing Category
C73594
G
Generic Name
ropivacaine hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL, EPIDURAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ROPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V910P86109
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT