FDA.reportPublic FDA data

Nicotine

Product NDC
0536-5896
11-digit product format
005365896
Labeler code
0536
Product ID
0536-5896_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
21 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
NICOTINE21 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
0536-5896-532024-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-712024-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-882024-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-532023-01-30C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-712023-01-30C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-882023-01-30C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-532021-02-23C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-712021-02-23C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-882021-02-23C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-532021-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-712021-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System
0536-5896-882021-01-29C16284748780-1ba0f9c33-5940-a910-e053-dadaa90a0b85Nicotine Transdermal System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-5896-53Nicotine1 h in 1 POUCHPATCH116
0536-5896-53Nicotine7 in 1 CARTONPATCH716
0536-5896-71Nicotine1 h in 1 POUCHPATCH116
0536-5896-71Nicotine28 in 1 CARTONPATCH2816
0536-5896-88Nicotine1 h in 1 POUCHPATCH116
0536-5896-88Nicotine14 in 1 CARTONPATCH1416

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-5896NICOTINE 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
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN9265d2b3-1f87-45ea-ba0a-5192175b43092
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD9265d2b3-1f87-45ea-ba0a-5192175b43092
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY9265d2b3-1f87-45ea-ba0a-5192175b43092
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY9265d2b3-1f87-45ea-ba0a-5192175b43092
198030nicotine 21 MG/Day 24HR Transdermal SystemSY9265d2b3-1f87-45ea-ba0a-5192175b43092
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN0d026350-1c4e-4377-b24e-b586cbc794e51
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD0d026350-1c4e-4377-b24e-b586cbc794e51
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY0d026350-1c4e-4377-b24e-b586cbc794e51
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY0d026350-1c4e-4377-b24e-b586cbc794e51
198030nicotine 21 MG/Day 24HR Transdermal SystemSY0d026350-1c4e-4377-b24e-b586cbc794e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-5896-53005365896537 POUCH in 1 CARTON (0536-5896-53) / 1 h in 1 POUCH7 pouch2024-06-250000-00-00NoNoCurrent
0536-5896-710053658967128 POUCH in 1 CARTON (0536-5896-71) / 1 h in 1 POUCH28 pouch2024-06-250000-00-00NoNoCurrent
0536-5896-880053658968814 POUCH in 1 CARTON (0536-5896-88) / 1 h in 1 POUCH14 pouch2024-06-250000-00-00NoNoCurrent