Lidocaine Hydrochloride
LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION, USP (VISCOUS) 2%
Approved
Approval ID
2de0a467-1338-4515-8a94-0d6d85e204ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2021
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
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 Code17856-0775
Application NumberANDA040014
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationORAL, TOPICAL
Effective DateJanuary 28, 2021
FDA Product Classification
INGREDIENTS (9)
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 20 mg in 1 mL
Code: EC2CNF7XFP
Classification: ACTIB