FDA.reportPublic FDA data

Nicotine

Product NDC
43598-445
11-digit product format
435980445
Labeler code
43598
Product ID
43598-445_8dd0ce2f-82c4-2685-3981-fa22b64b3208
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
KIT
Route
TRANSDERMAL
Labeler
Dr. Reddys 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
43598-445-282024-01-30C16284748780-11030e365-3e2d-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-445-56Nicotine transdermal system1 in 1 PATCHKIT121
43598-445-56Nicotine transdermal system56 in 1 CARTONKIT5621

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-445-56EA - Each43598-44547641a53-e58f-40d8-b6eb-19cc20af359f12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NicotineACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM (NICOTINE ) KIT [DR. REDDY'S LABORATORIES LIMITED]4
NicotineACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM (NICOTINE ) KIT [DR. REDDY'S LABORATORIES LIMITED]4
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM (NICOTINE ) KIT [DR. REDDY'S LABORATORIES LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-445NICOTINE TRANSDERMAL SYSTEM (NICOTINE) KIT [DR. REDDYS LABORATORIES INC.]21Current NDC, Legacy NDC, 2 package rows20240726_e2391b29-9bac-fc09-f2a5-a3370bc4e2c3.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) } PackGPCKe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
892244nicotine 21 MG-14 MG-7 MG 24 HR Transdermal System Kit (56)PSNe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
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) } PackSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198029nicotine 14 MG/Day 24HR Transdermal SystemSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198030nicotine 21 MG/Day 24HR Transdermal SystemSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
892244nicotine 7 MG-14 MG-21 MG in 24 HR Transdermal System KitSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
198031nicotine 7 MG/Day 24HR Transdermal SystemSYe2391b29-9bac-fc09-f2a5-a3370bc4e2c321
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) } PackGPCKae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNae6027da-5c96-ed47-e1ae-e900fc0f72ce4
892244nicotine 21 MG-14 MG-7 MG 24 HR Transdermal System Kit (56)PSNae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNae6027da-5c96-ed47-e1ae-e900fc0f72ce4
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDae6027da-5c96-ed47-e1ae-e900fc0f72ce4
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDae6027da-5c96-ed47-e1ae-e900fc0f72ce4
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDae6027da-5c96-ed47-e1ae-e900fc0f72ce4
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) } PackSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198029nicotine 14 MG/Day 24HR Transdermal SystemSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198030nicotine 21 MG/Day 24HR Transdermal SystemSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
892244nicotine 7 MG-14 MG-21 MG in 24 HR Transdermal System KitSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4
198031nicotine 7 MG/Day 24HR Transdermal SystemSYae6027da-5c96-ed47-e1ae-e900fc0f72ce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-445-284359804452856 PATCH in 1 CARTON (43598-445-28) > 1 KIT in 1 PATCH (43598-445-56) 56 patch2015-05-140000-00-00NoNoCurrent
43598-445-564359804455656 PATCH in 1 CARTON (43598-445-56) / 1 KIT in 1 PATCH56 patch2015-05-14NoNoHistorical