NA
Lidocaine Hydrochloride Injection USP 4% [200 mg/5 mL (40 mg/mL)] Single-dose ampules ONLY FOR TOPICAL USE AND RETROBULBAR INJECTION.Rx only
Approved
Approval ID
a7529e5b-47b1-4148-98dd-65aecc33a8c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Sintetica US LLC
DUNS: 118837338
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83090-007
Application NumberANDA214269
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationRETROBULBAR
Effective DateDecember 15, 2022
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 40 mg in 1 mL
Code: EC2CNF7XFP
Classification: ACTIB