Home NDC 3215-0121-14 Nicotine Transdermal System
Product NDC 3215-0121
Requested package NDC 3215-0121-14
11-digit product format 032150121
Labeler code 3215
Product ID 3215-0121_43e1a5a7-e10f-afa8-e063-6294a90a254e
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Transdermal System
Dosage form PATCH
Route TRANSDERMAL
Labeler Aveva Drug Delivery Systems, Inc.
Application ANDA074612
Marketing category ANDA
Marketing start 2025-11-24
Substance NICOTINE
Active strength 14 mg/24h
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 14 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 3215-0121-14 Nicotine Transdermal System 1 h in 1 PATCH PATCH 1 1 3215-0121-14 Nicotine Transdermal System 14 in 1 CARTON PATCH 14 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 3215-0121-14 03215012114 14 PATCH in 1 CARTON (3215-0121-14) / 1 h in 1 PATCH 14 patch 2025-11-24 No No Current