Nicotine Transdermal System

Product NDC
70000-0761
11-digit product format
700000761
Labeler code
70000
Product ID
70000-0761_2ffcf657-7e4f-d67f-1bf7-38bd7fb4946a
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
NDA020076
Marketing category
NDA
Marketing start
2026-03-20
Substance
NICOTINE
Active strength
14 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Transdermal System
Brand name suffix
step 2
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE14 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui198029, 198030, 198031

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0761-1Nicotine Transdermal System step 224 h in 1 PATCHPATCH, EXTENDED RELEASE241
70000-0761-1Nicotine Transdermal System step 27 in 1 CARTONPATCH, EXTENDED RELEASE71
70000-0761-2Nicotine Transdermal System step 224 h in 1 PATCHPATCH, EXTENDED RELEASE241
70000-0761-2Nicotine Transdermal System step 214 in 1 CARTONPATCH, EXTENDED RELEASE141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNdbbed17b-8ad3-05fb-fb63-03fbb75eae051
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDdbbed17b-8ad3-05fb-fb63-03fbb75eae051
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDdbbed17b-8ad3-05fb-fb63-03fbb75eae051
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198029nicotine 14 MG/Day 24HR Transdermal SystemSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198030nicotine 21 MG/Day 24HR Transdermal SystemSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051
198031nicotine 7 MG/Day 24HR Transdermal SystemSYdbbed17b-8ad3-05fb-fb63-03fbb75eae051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0761-1700000761017 PATCH in 1 CARTON (70000-0761-1) / 24 h in 1 PATCH7 patch2026-03-20NoNoHistorical
70000-0761-27000007610214 PATCH in 1 CARTON (70000-0761-2) / 24 h in 1 PATCH14 patch2026-03-20NoNoHistorical