NICOTINE

Product NDC
50090-2860
11-digit product format
500902860
Labeler code
50090
Product ID
50090-2860_dedf78f2-a69f-4b0b-b47b-4838897d1402
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
A-S Medication Solutions
Application
NDA020076
Marketing category
NDA
Marketing start
2015-05-14
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
21 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2860IInactivated by FDA2026-07-31
excluded packagepackage50090-286050090-2860-0IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020076-004HABITROLNICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-005HABITROLNICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-006HABITROLNICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Transdermal System Patch Step 3NICOTINE TRANSDERMAL SYSTEM PATCHBluePoint Laboratories4856e99a-badc-b957-e063-6294a90a86062026-07-10WarningsExact identifier
Nicotine Transdermal System step 3NICOTINEAmerisourceBergen Drug Corporatione51d2c09-a20f-eb9b-e3e4-013f3e488ab32026-07-01WarningsExact identifier
Nicotine transdermal system step 3NICOTINERugby Laboratoriesae406389-0f83-d5c8-bd2f-56075e57453a2026-03-25WarningsExact identifier
Nicotine Transdermal System step 3NICOTINECARDINAL HEALTH 110, LLC. DBA LEADERdbbed17b-8ad3-05fb-fb63-03fbb75eae052026-03-18WarningsExact identifier
NICOTINE TRANSDERMAL SYSTEMNICOTINEA-S Medication Solutionscfb56e3e-ac5d-4086-a5d3-23080844b3e12026-03-13WarningsExact identifier
Nicotine transdermal system step 3NICOTINEGolden State Medical Supply, Inc.7c83d507-7e8d-496c-bb9d-63abfa25c7a72025-04-17WarningsExact identifier
Nicotine transdermal system step 3NICOTINECVS Pharmacyd51d5224-f5bf-2510-1fa0-c4bb454f81602024-12-01WarningsExact identifier
Nicotine transdermal system step 3NICOTINEStrategic Sourcing Services LLC6c0b5b5c-cc76-6e48-c364-4db0e081557d2024-11-09WarningsExact identifier
Nicotine transdermal system step 3NICOTINERite Aid Corporationd2e32434-ec58-943e-dbeb-8e73315315952024-07-26WarningsExact identifier
NICOTINE TRANSDERMALNICOTINERite Aid Corporationae6027da-5c96-ed47-e1ae-e900fc0f72ce2024-07-26WarningsExact identifier
Nicotine transdermal system step 3NICOTINEThe Kroger Co.13cdd780-4196-685b-3cab-f9694a3276182024-07-25WarningsExact identifier
Habitrol Step 3NICOTINE TRANSDERMAL SYSTEM PATCHDr. Reddy's Laboratories Inc.051be7ae-6504-c2d8-7424-2e328e4fcfc22024-07-25WarningsExact identifier
Nicotine transdermal system step 2NICOTINEChain Drug Marketing Association INCdf1348cb-0d15-7e4b-921c-d8764c858e662024-07-25WarningsExact identifier
Nicotine transdermal systemNICOTINEDr. Reddys Laboratories Inc.e2391b29-9bac-fc09-f2a5-a3370bc4e2c32024-07-25WarningsExact identifier
nicotine transdermal systemNICOTINEDr. Reddy's Laboratories Inc.b9946e3c-80c9-3076-7c32-e2988ac070482024-07-25WarningsExact identifier
Nicotine transdermal system step 1NICOTINEDOLGENCORP, LLC81e55db2-897e-e567-5743-63179783291a2024-07-25WarningsExact identifier
Nicotine transdermal system step 3NICOTINEWalgreens Companyde471db4-b332-0490-198d-d354802728742024-07-25WarningsExact identifier
Nicotine transdermal system step 3NICOTINEDr. Reddy's Laboratories Inc.3a68eb70-0548-fa6f-8b1c-375e8799f24f2024-07-24WarningsExact identifier
Nicotine transdermal system step 3NICOTINEA-S Medication Solutions798a66fa-25d8-4713-b25f-56875431e37d2023-03-02WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS SECTION If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have • Heart disease, recent heart attack, or irregular heartbeat. • Nicotine can increase your heart rate.high blood pressure not controlled with medication. • Nicotine can increase your blood pressure. • An allergy to adhesive tape or have skin problems, because you are more likely to get rashes. • Stomach ulcer or diabetes.history of seizures. Ask a doctor or pharmacist before use if you are • using a non-nicotine stop smoking drug • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rashirregular heartbeat or palpitations occur you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

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
50090-2860-02024-01-30C16284748780-19d75b9d0-524b-f424-e053-dadaa90a57ceDrug Facts
50090-2860-02021-09-17C16284748780-19d75b9d0-524b-f424-e053-dadaa90a57ceDrug Facts
50090-2860-02020-01-31C16284748780-19d75b9d0-524b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2860-0NICOTINE TRANSDERMAL SYSTEM STEP 114 in 1 CARTONPATCH, EXTENDED RELEASE1419
50090-2860-0NICOTINE TRANSDERMAL SYSTEM STEP 124 h in 1 PATCHPATCH, EXTENDED RELEASE2419

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2860-0EA - Each50090-286059938d2f-61ed-4396-b6d8-a1fada77cc0512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2860NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]19Legacy NDC, 2 package rows20221206_44536fb0-dc5d-4c50-8d10-19dd9a0d9978.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN44536fb0-dc5d-4c50-8d10-19dd9a0d997819
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198030nicotine 21 MG/Day 24HR Transdermal SystemSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2860-05009028600014 PATCH in 1 CARTON (50090-2860-0) > 24 h in 1 PATCH14 patch2017-02-100000-00-00NoNoCurrent