Nicotine Transdermal System

Product NDC
0363-1244
11-digit product format
003631244
Labeler code
0363
Product ID
0363-1244_312d989c-79f6-8f42-e063-6294a90aa812
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Walgreens
Application
ANDA074612
Marketing category
ANDA
Marketing start
2024-09-30
Substance
NICOTINE
Active strength
14 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Transdermal System
Listing expiration
2026-12-31

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
0363-1244-01Nicotine Transdermal System14 in 1 CARTONPATCH, EXTENDED RELEASE147
0363-1244-01Nicotine Transdermal System1 h in 1 POUCHPATCH, EXTENDED RELEASE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1244NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [WALGREENS]7Current NDC, Legacy NDC, 2 package rows20250327_5aadb95f-428c-b637-01f4-50d5866ced0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN5aadb95f-428c-b637-01f4-50d5866ced0c7
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN5aadb95f-428c-b637-01f4-50d5866ced0c7
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN5aadb95f-428c-b637-01f4-50d5866ced0c7
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD5aadb95f-428c-b637-01f4-50d5866ced0c7
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD5aadb95f-428c-b637-01f4-50d5866ced0c7
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD5aadb95f-428c-b637-01f4-50d5866ced0c7
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198029nicotine 14 MG/Day 24HR Transdermal SystemSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198030nicotine 21 MG/Day 24HR Transdermal SystemSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198031nicotine 7 MG/Day 24HR Transdermal SystemSY5aadb95f-428c-b637-01f4-50d5866ced0c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1244-010036312440114 POUCH in 1 CARTON (0363-1244-01) / 1 h in 1 POUCH14 pouch2024-09-300000-00-00NoNoCurrent