FDA.reportPublic FDA data

Nicotine Transdermal System

Product NDC
3215-1202
11-digit product format
032151202
Labeler code
3215
Product ID
3215-1202_3b26fb9e-e895-8cf8-e063-6294a90af3b5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Aveva Drug Delivery Systems Inc.
Application
ANDA074612
Marketing category
ANDA
Marketing start
2024-06-25
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
3215-1202-07Nicotine Transdermal System24 h in 1 POUCHPATCH241
3215-1202-07Nicotine Transdermal System7 in 1 CARTONPATCH71
3215-1202-14Nicotine Transdermal System14 in 1 CARTONPATCH141
3215-1202-14Nicotine Transdermal System24 h in 1 POUCHPATCH241
3215-1202-28Nicotine Transdermal System24 h in 1 POUCHPATCH241
3215-1202-28Nicotine Transdermal System28 in 1 CARTONPATCH281

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198029nicotine 14 MG/Day 24HR Transdermal SystemSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198030nicotine 21 MG/Day 24HR Transdermal SystemSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198031nicotine 7 MG/Day 24HR Transdermal SystemSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
3215-1202-07032151202077 POUCH in 1 CARTON (3215-1202-07) / 24 h in 1 POUCH7 pouch2024-06-25NoNoCurrent
3215-1202-140321512021414 POUCH in 1 CARTON (3215-1202-14) / 24 h in 1 POUCH14 pouch2024-06-25NoNoCurrent
3215-1202-280321512022828 POUCH in 1 CARTON (3215-1202-28) / 24 h in 1 POUCH28 pouch2024-06-25NoNoCurrent