FDA.reportPublic FDA data

Nicotine

Product NDC
0536-5895
11-digit product format
005365895
Labeler code
0536
Product ID
0536-5895_1a266044-8837-71cc-e063-6394a90afcc0
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Rugby Laboratories
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-5895-532024-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-712024-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-882024-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-532023-01-30C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-712023-01-30C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-882023-01-30C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-532021-02-23C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-712021-02-23C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-882021-02-23C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-532021-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-712021-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5895-882021-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-5895-53Nicotine7 in 1 CARTONPATCH716
0536-5895-53Nicotine1 h in 1 POUCHPATCH116
0536-5895-71Nicotine28 in 1 CARTONPATCH2816
0536-5895-71Nicotine1 h in 1 POUCHPATCH116
0536-5895-88Nicotine1 h in 1 POUCHPATCH116
0536-5895-88Nicotine14 in 1 CARTONPATCH1416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-5895-33EA - Each0536-589563ad1db9-145b-46b4-825c-6dd446714b3b12015-06-09
0536-5895-53EA - Each0536-58950da8c4fd-bcf0-48c2-a3cc-66177e0b574a12017-06-15
0536-5895-71EA - Each0536-58953e810ef8-444b-4469-86ef-631f7f01572f12019-10-07
0536-5895-88EA - Each0536-5895d359ffb1-33ff-40b0-8b63-b75a9583e17212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE PATCH [RUGBY LABORATORIES]9
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE PATCH [RUGBY LABORATORIES]9
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONICOTINE PATCH [RUGBY LABORATORIES]9
NicotineACTIVE INGREDIENT6M3C89ZY6RNICOTINE PATCH [TYA PHARMACEUTICALS]2
NicotineACTIVE MOIETY6M3C89ZY6RNICOTINE PATCH [TYA PHARMACEUTICALS]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONICOTINE PATCH [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-5895NICOTINE PATCH [RUGBY LABORATORIES]16Current NDC, Legacy NDC, 6 package rows20240625_2dd4cbda-5c46-4655-b69d-21b7d2e912cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN13aa171e-7425-47fc-b618-7759840f061831
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN13aa171e-7425-47fc-b618-7759840f061831
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN13aa171e-7425-47fc-b618-7759840f061831
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD13aa171e-7425-47fc-b618-7759840f061831
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD13aa171e-7425-47fc-b618-7759840f061831
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD13aa171e-7425-47fc-b618-7759840f061831
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY13aa171e-7425-47fc-b618-7759840f061831
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY13aa171e-7425-47fc-b618-7759840f061831
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY13aa171e-7425-47fc-b618-7759840f061831
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY13aa171e-7425-47fc-b618-7759840f061831
198029nicotine 14 MG/Day 24HR Transdermal SystemSY13aa171e-7425-47fc-b618-7759840f061831
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY13aa171e-7425-47fc-b618-7759840f061831
198030nicotine 21 MG/Day 24HR Transdermal SystemSY13aa171e-7425-47fc-b618-7759840f061831
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY13aa171e-7425-47fc-b618-7759840f061831
198031nicotine 7 MG/Day 24HR Transdermal SystemSY13aa171e-7425-47fc-b618-7759840f061831
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198029nicotine 14 MG/Day 24HR Transdermal SystemSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198030nicotine 21 MG/Day 24HR Transdermal SystemSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198031nicotine 7 MG/Day 24HR Transdermal SystemSY2dd4cbda-5c46-4655-b69d-21b7d2e912cf16
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNf00d85f4-2b4f-4281-b72e-9de730140e412
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDf00d85f4-2b4f-4281-b72e-9de730140e412
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYf00d85f4-2b4f-4281-b72e-9de730140e412
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYf00d85f4-2b4f-4281-b72e-9de730140e412
198029nicotine 14 MG/Day 24HR Transdermal SystemSYf00d85f4-2b4f-4281-b72e-9de730140e412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-5895-53005365895537 POUCH in 1 CARTON (0536-5895-53) / 1 h in 1 POUCH7 pouch2024-06-250000-00-00NoNoCurrent
0536-5895-710053658957128 POUCH in 1 CARTON (0536-5895-71) / 1 h in 1 POUCH28 pouch2024-06-250000-00-00NoNoCurrent
0536-5895-880053658958814 POUCH in 1 CARTON (0536-5895-88) / 1 h in 1 POUCH14 pouch2024-06-250000-00-00NoNoCurrent