FDA.reportPublic FDA data

Nicotine

Product NDC
11673-194
11-digit product format
116730194
Labeler code
11673
Product ID
11673-194_63a80823-85d8-4e21-af30-79018b0e2a72
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Target Corporation
Application
NDA020165
Marketing category
NDA
Marketing start
2000-02-16
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
Brand name suffix
transdermal system
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
11673-194-012024-03-21C16284748780-1ba0f9c33-19d9-a910-e053-dadaa90a0b85Drug Facts
11673-194-022024-03-21C16284748780-1ba0f9c33-19d9-a910-e053-dadaa90a0b85Drug Facts
11673-194-012024-01-30C16284748780-1ba0f9c33-19d9-a910-e053-dadaa90a0b85Drug Facts
11673-194-022024-01-30C16284748780-1ba0f9c33-19d9-a910-e053-dadaa90a0b85Drug Facts
11673-194-012021-12-16C16284748780-1ba0f9c33-19d9-a910-e053-dadaa90a0b85Drug Facts
11673-194-022021-12-16C16284748780-1ba0f9c33-19d9-a910-e053-dadaa90a0b85Drug Facts
11673-194-012021-01-29C16284748780-1ba0f9c33-19d9-a910-e053-dadaa90a0b85Drug Facts
11673-194-022021-01-29C16284748780-1ba0f9c33-19d9-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-194-01Nicotinetransdermal system24 h in 1 PATCHPATCH, EXTENDED RELEASE2416
11673-194-01Nicotinetransdermal system7 in 1 CARTONPATCH, EXTENDED RELEASE716
11673-194-02Nicotinetransdermal system24 h in 1 PATCHPATCH, EXTENDED RELEASE2416
11673-194-02Nicotinetransdermal system14 in 1 CARTONPATCH, EXTENDED RELEASE1416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-194-01EA - Each11673-194ee44b169-b32a-4daa-8036-6b29917d56ad12015-09-10
11673-194-02EA - Each11673-19499301a0b-1139-45f8-925b-141532006ff812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [TARGET CORPORATION]8
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [TARGET CORPORATION]8
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZUNICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [TARGET CORPORATION]8
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [TARGET CORPORATION]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-194NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [TARGET CORPORATION]15Current NDC, Legacy NDC, 4 package rows20241222_f8d6bf61-6d66-4651-8145-c4cb1d5e443f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198029nicotine 14 MG/Day 24HR Transdermal SystemSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198030nicotine 21 MG/Day 24HR Transdermal SystemSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16
198031nicotine 7 MG/Day 24HR Transdermal SystemSYf8d6bf61-6d66-4651-8145-c4cb1d5e443f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-194-01116730194017 PATCH in 1 CARTON (11673-194-01) > 24 h in 1 PATCH7 patch2000-02-160000-00-00NoNoCurrent
11673-194-021167301940214 PATCH in 1 CARTON (11673-194-02) / 24 h in 1 PATCH14 patch2000-02-160000-00-00NoNoCurrent