Nicotine Transdermal System

Product NDC
84720-121
11-digit product format
847200121
Labeler code
84720
Product ID
84720-121_4e40a83a-b6e0-fc37-e063-6394a90ac410
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Quitine LLC
Application
ANDA074612
Marketing category
ANDA
Marketing start
2026-03-26
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
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
84720-121-14Nicotine Transdermal System1 h in 1 PATCHPATCH11
84720-121-14Nicotine Transdermal System14 in 1 CARTONPATCH141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNe4761ed6-509b-4e43-88e0-b0229d24859a1
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNe4761ed6-509b-4e43-88e0-b0229d24859a1
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNe4761ed6-509b-4e43-88e0-b0229d24859a1
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDe4761ed6-509b-4e43-88e0-b0229d24859a1
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDe4761ed6-509b-4e43-88e0-b0229d24859a1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDe4761ed6-509b-4e43-88e0-b0229d24859a1
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYe4761ed6-509b-4e43-88e0-b0229d24859a1
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYe4761ed6-509b-4e43-88e0-b0229d24859a1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYe4761ed6-509b-4e43-88e0-b0229d24859a1
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYe4761ed6-509b-4e43-88e0-b0229d24859a1
198029nicotine 14 MG/Day 24HR Transdermal SystemSYe4761ed6-509b-4e43-88e0-b0229d24859a1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYe4761ed6-509b-4e43-88e0-b0229d24859a1
198030nicotine 21 MG/Day 24HR Transdermal SystemSYe4761ed6-509b-4e43-88e0-b0229d24859a1
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYe4761ed6-509b-4e43-88e0-b0229d24859a1
198031nicotine 7 MG/Day 24HR Transdermal SystemSYe4761ed6-509b-4e43-88e0-b0229d24859a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84720-121-148472001211414 PATCH in 1 CARTON (84720-121-14) / 1 h in 1 PATCH14 patch2026-03-26NoNoHistorical