Home NDC 50090-2860-0 NICOTINE
Product NDC 50090-2860
Requested package NDC 50090-2860-0
11-digit product format 500902860
Labeler code 50090
Product ID 50090-2860_dedf78f2-a69f-4b0b-b47b-4838897d1402
Type HUMAN OTC DRUG
Nonproprietary name NICOTINE
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler A-S Medication Solutions
Application NDA020076
Marketing category NDA
Marketing start 2015-05-14
Marketing end 0000-00-00
Substance NICOTINE
Active strength 21 mg/24h
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 N020076-004 HABITROL NICOTINE 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 N020076-005 HABITROL NICOTINE 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 N020076-006 HABITROL NICOTINE 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12
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 N020076-004 HABITROL 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N020076-005 HABITROL 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 1999-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N020076-006 HABITROL 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 1999-11-12 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 · 19 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 50090-2860-0 NICOTINE TRANSDERMAL SYSTEM STEP 1 14 in 1 CARTON PATCH, EXTENDED RELEASE 14 19 50090-2860-0 NICOTINE TRANSDERMAL SYSTEM STEP 1 24 h in 1 PATCH PATCH, EXTENDED RELEASE 24 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2860 NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] 19 Legacy NDC, 2 package rows 20221206_44536fb0-dc5d-4c50-8d10-19dd9a0d9978.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 50090-2860-0 50090286000 14 PATCH in 1 CARTON (50090-2860-0) > 24 h in 1 PATCH 14 patch 2017-02-10 0000-00-00 No No Current