Lidocaine

Product NDC
0378-9055
11-digit product format
003789055
Labeler code
0378
Product ID
0378-9055_99a8db07-5d64-4bc4-9fa7-3fd44ca73d27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202346
Marketing category
ANDA
Marketing start
2015-08-07
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
140 mg/1
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9055-16EA - Each0378-905502088343-e601-4b03-ad02-38557a9fa6d512020-02-13
0378-9055-93EA - Each0378-90553cf25faa-3fc4-42c0-b769-4e2dbebd052c12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE PATCH [MYLAN PHARMACEUTICALS INC.]3
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE PATCH [MYLAN PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9055LIDOCAINE PATCH [MYLAN PHARMACEUTICALS INC.]9Legacy NDC20250104_5c66f3b9-6e04-47ab-8d94-21e89ceec154.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9055-930037890559330 POUCH in 1 CARTON (0378-9055-93) > 1 PATCH in 1 POUCH (0378-9055-16) 30 pouch2015-08-070000-00-00NoNoCurrent