NESACAINE
451109G /Revised: April 2019
Approved
Approval ID
823a2335-05d0-4391-b612-316bfee9b1ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Henry Schein, Inc.
DUNS: 012430880
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
chloroprocaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-9927
Application NumberNDA009435
Product Classification
M
Marketing Category
C73594
G
Generic Name
chloroprocaine hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 4.7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.111 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
CHLOROPROCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: LT7Z1YW11H
Classification: ACTIB
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT