FDA.reportPublic FDA data

Nicotine Transdermal System

Product NDC
36800-032
11-digit product format
368000032
Labeler code
36800
Product ID
36800-032_4c5aeba4-a6e6-6b3a-e063-6294a90aaed4
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Topco Associates LLC
Application
ANDA074612
Marketing category
ANDA
Marketing start
2024-06-25
Substance
NICOTINE
Active strength
7 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Transdermal System
Listing expiration
2027-12-31

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
36800-032-142026-01-29C16284748780-149896155-ac87-586f-e063-e6dba90add90Nicotine Transdermal System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-032-14Nicotine Transdermal System14 in 1 CARTONPATCH, EXTENDED RELEASE149
36800-032-14Nicotine Transdermal System1 h in 1 POUCHPATCH, EXTENDED RELEASE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-032-14EA - Each36800-032ef080c54-a00b-4f2a-b0b3-ca8663de7fa912018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-032NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 2 package rows20240625_a631d31d-38e6-1772-8b6d-57672b785d98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNa631d31d-38e6-1772-8b6d-57672b785d989
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNa631d31d-38e6-1772-8b6d-57672b785d989
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNa631d31d-38e6-1772-8b6d-57672b785d989
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDa631d31d-38e6-1772-8b6d-57672b785d989
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDa631d31d-38e6-1772-8b6d-57672b785d989
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDa631d31d-38e6-1772-8b6d-57672b785d989
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYa631d31d-38e6-1772-8b6d-57672b785d989
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYa631d31d-38e6-1772-8b6d-57672b785d989
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYa631d31d-38e6-1772-8b6d-57672b785d989
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYa631d31d-38e6-1772-8b6d-57672b785d989
198029nicotine 14 MG/Day 24HR Transdermal SystemSYa631d31d-38e6-1772-8b6d-57672b785d989
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYa631d31d-38e6-1772-8b6d-57672b785d989
198030nicotine 21 MG/Day 24HR Transdermal SystemSYa631d31d-38e6-1772-8b6d-57672b785d989
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYa631d31d-38e6-1772-8b6d-57672b785d989
198031nicotine 7 MG/Day 24HR Transdermal SystemSYa631d31d-38e6-1772-8b6d-57672b785d989

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-032-143680000321414 POUCH in 1 CARTON (36800-032-14) / 1 h in 1 POUCH14 pouch2024-06-250000-00-00NoNoCurrent