FDA.reportPublic FDA data

Nicotine

Product NDC
50090-1697
11-digit product format
500901697
Labeler code
50090
Product ID
50090-1697_91b95e4b-92df-40cc-9875-bec23c0d4475
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
A-S Medication Solutions
Application
ANDA074612
Marketing category
ANDA
Marketing start
1997-10-20
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
50090-1697-02023-02-07C16284748780-19d75b9d0-9c0d-f424-e053-dadaa90a57ceNicotine Transdermal System
50090-1697-02023-01-30C16284748780-19d75b9d0-9c0d-f424-e053-dadaa90a57ceNicotine Transdermal System
50090-1697-02020-02-14C16284748780-19d75b9d0-9c0d-f424-e053-dadaa90a57ceNicotine Transdermal System
50090-1697-02020-01-31C16284748780-19d75b9d0-9c0d-f424-e053-dadaa90a57ceNicotine Transdermal System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1697-0Nicotine1 h in 1 POUCHPATCH131
50090-1697-0Nicotine14 in 1 CARTONPATCH1431

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1697NICOTINE PATCH [A-S MEDICATION SOLUTIONS]29Current NDC, Legacy NDC, 2 package rows20240516_13aa171e-7425-47fc-b618-7759840f0618.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1697-05009016970014 POUCH in 1 CARTON (50090-1697-0) / 1 h in 1 POUCH14 pouch2015-02-130000-00-00NoNoCurrent