Lidocaine Hydrochloride and Epinephrine
Lidocaine HCL 0.5% and Epinephrine 1:200,000 Injection, USP 50 mL Multi Dose Vial
Approved
Approval ID
5569d607-f1cb-4f1d-8a00-d50433ec05d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 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.
Lidocaine Hydrochloride and Epinephrine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-9886
Application NumberANDA089635
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride and Epinephrine
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateJanuary 11, 2022
FDA Product Classification
INGREDIENTS (9)
EpinephrineActive
Quantity: 5 ug in 1 mL
Code: YKH834O4BH
Classification: ACTIB
LIDOCAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: .5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: .2 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT