Leader Nicotine

Product NDC
70000-0117
11-digit product format
700000117
Labeler code
70000
Product ID
70000-0117_24ab5894-ad52-453b-a3ed-263cb6af5bf5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA203690
Marketing category
ANDA
Marketing start
2016-09-20
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0117-1EA - Each70000-0117719be69a-f1be-46b6-ba5b-1ac9328d63b212017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0117LEADER NICOTINE (NICOTINE POLACRILEX) LOZENGE [CARDINAL HEALTH 110, LLC. DBA LEADER]2Legacy NDC20210701_49871743-6a6d-4f76-972d-a272baaeae65.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0117-1700000117013 CONTAINER in 1 CARTON (70000-0117-1) > 27 LOZENGE in 1 CONTAINER3 container2016-09-200000-00-00NoNoCurrent