FDA.reportPublic FDA data

Nicotine

Product NDC
11822-4973
11-digit product format
118224973
Labeler code
11822
Product ID
11822-4973_31036926-dedd-9ff4-05eb-ebc5a28af900
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Rite Aid Corporation
Application
NDA020076
Marketing category
NDA
Marketing start
2015-05-14
Substance
NICOTINE
Active strength
7 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
Brand name suffix
transdermal system step 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE7 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
11822-4973-02024-01-30C16284748780-1d6a99b39-85c8-a426-e053-dadaa90af4c2d2e32434-ec58-943e-dbeb-8e7331531595
11822-4973-02022-11-10C16284748780-1d6a99b39-85c8-a426-e053-dadaa90af4c2d2e32434-ec58-943e-dbeb-8e7331531595
11822-4973-02022-01-28C16284748780-1d6a99b39-85c8-a426-e053-dadaa90af4c2d2e32434-ec58-943e-dbeb-8e7331531595

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4973NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [RITE AID CORPORATION]7Current NDC, Legacy NDC20240727_d2e32434-ec58-943e-dbeb-8e7331531595.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNd2e32434-ec58-943e-dbeb-8e73315315957
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNd2e32434-ec58-943e-dbeb-8e73315315957
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNd2e32434-ec58-943e-dbeb-8e73315315957
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDd2e32434-ec58-943e-dbeb-8e73315315957
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDd2e32434-ec58-943e-dbeb-8e73315315957
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDd2e32434-ec58-943e-dbeb-8e73315315957
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198029nicotine 14 MG/Day 24HR Transdermal SystemSYd2e32434-ec58-943e-dbeb-8e73315315957
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198030nicotine 21 MG/Day 24HR Transdermal SystemSYd2e32434-ec58-943e-dbeb-8e73315315957
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198031nicotine 7 MG/Day 24HR Transdermal SystemSYd2e32434-ec58-943e-dbeb-8e73315315957

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-4973-01182249730014 PATCH in 1 CARTON (11822-4973-0) / 24 h in 1 PATCH14 patch2015-05-140000-00-00NoNoCurrent