FDA.reportPublic FDA data

nicotine

Product NDC
55741-449
11-digit product format
557410449
Labeler code
55741
Product ID
55741-449_bed562f2-f5b3-632b-4b2c-fdf34a061098
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
KIT
Route
TRANSDERMAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
NDA020076
Marketing category
NDA
Marketing start
2015-05-14
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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui198029, 198030, 198031, 892244

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
55741-449-562024-01-30C16284748780-11030e365-5685-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-449-56nicotine transdermal system56 in 1 CARTONKIT564
55741-449-56nicotine transdermal system1 in 1 PATCHKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55741-449NICOTINE TRANSDERMAL SYSTEM (NICOTINE) KIT [DR. REDDY'S LABORATORIES INC.]4Current NDC, Legacy NDC, 2 package rows20240726_b9946e3c-80c9-3076-7c32-e2988ac07048.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892244{14 (24 HR nicotine 0.292 MG/HR Transdermal System) / 14 (24 HR nicotine 0.583 MG/HR Transdermal System) / 28 (24 HR nicotine 0.875 MG/HR Transdermal System) } PackGPCKb9946e3c-80c9-3076-7c32-e2988ac070484
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNb9946e3c-80c9-3076-7c32-e2988ac070484
892244nicotine 21 MG-14 MG-7 MG 24 HR Transdermal System Kit (56)PSNb9946e3c-80c9-3076-7c32-e2988ac070484
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNb9946e3c-80c9-3076-7c32-e2988ac070484
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNb9946e3c-80c9-3076-7c32-e2988ac070484
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDb9946e3c-80c9-3076-7c32-e2988ac070484
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDb9946e3c-80c9-3076-7c32-e2988ac070484
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDb9946e3c-80c9-3076-7c32-e2988ac070484
892244{28 (nicotine 21 MG per 24HR 1 Day Transdermal Patch) / 14 (nicotine 14 MG per 24HR 1 Day Transdermal Patch) / 14 (nicotine 7 MG per 24HR 1 Day Transdermal Patch) } PackSYb9946e3c-80c9-3076-7c32-e2988ac070484
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198029nicotine 14 MG/Day 24HR Transdermal SystemSYb9946e3c-80c9-3076-7c32-e2988ac070484
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198030nicotine 21 MG/Day 24HR Transdermal SystemSYb9946e3c-80c9-3076-7c32-e2988ac070484
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
892244nicotine 7 MG-14 MG-21 MG in 24 HR Transdermal System KitSYb9946e3c-80c9-3076-7c32-e2988ac070484
198031nicotine 7 MG/Day 24HR Transdermal SystemSYb9946e3c-80c9-3076-7c32-e2988ac070484

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55741-449-565574104495656 PATCH in 1 CARTON (55741-449-56) / 1 KIT in 1 PATCH56 patch2015-05-140000-00-00NoNoCurrent