LIDOCAINE HYDROCHLORIDE

Product NDC
59651-943
11-digit product format
596510943
Labeler code
59651
Product ID
59651-943_ab461805-413a-4fb3-88a1-224e1c423084
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219759
Marketing category
ANDA
Marketing start
2025-07-29
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
V13007Z41ALIDOCAINE HYDROCHLORIDE6108-05-0LIDOCAINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-943-0159651094301100 mL in 1 BOTTLE (59651-943-01) 100 ml2025-07-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Viscous) Rx onlyAurobindo Pharma Limited2025-07-30Human Prescription Drug Label1