Home NDC 36800-038 Nicotine Transdermal System
Product NDC 36800-038
11-digit product format 368000038
Labeler code 36800
Product ID 36800-038_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 21 mg/24h
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074612-001 NICOTINE NICOTINE 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 1997-10-20 A074612-002 NICOTINE NICOTINE 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 2003-07-28 A074612-003 NICOTINE NICOTINE 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 1997-10-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A074612-001 NICOTINE 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 1997-10-20 a50c72e98297…2026-08-01 22:54:32 2026-06 A074612-002 NICOTINE 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 2003-07-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A074612-003 NICOTINE 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 1997-10-20 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 17 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nicotine Transdermal System
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 21 mg/24h
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M3C89ZY6R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198029 Internal RxNorm lookup 198030 Internal RxNorm lookup 198031 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-038-14 Nicotine Transdermal System 1 h in 1 POUCH PATCH, EXTENDED RELEASE 1 9 36800-038-14 Nicotine Transdermal System 14 in 1 CARTON PATCH, EXTENDED RELEASE 14 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-038 NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] 8 Current NDC, Legacy NDC, 2 package rows 20240625_a631d31d-38e6-1772-8b6d-57672b785d98.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-038-14 36800003814 14 POUCH in 1 CARTON (36800-038-14) / 1 h in 1 POUCH 14 pouch 2024-06-25 0000-00-00 No No Current