nicotine transdermal system

Generic: nicotine

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine transdermal system
Generic Name nicotine
Labeler exelan pharmaceuticals, inc.
Dosage Form FILM, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

nicotine 7 mg/24h

Manufacturer
EXELAN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 76282-781
Product ID 76282-781_2aec5dc5-7c75-43f4-b724-de29ac1f84cb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074612
Listing Expiration 2026-12-31
Marketing Start 2025-10-13

Pharmacologic Class

Established (EPC)
cholinergic nicotinic agonist [epc]
Chemical Structure
nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282781
Hyphenated Format 76282-781

Supplemental Identifiers

RxCUI
198029 198030 198031
UNII
6M3C89ZY6R
NUI
N0000175706 M0014836

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nicotine transdermal system (source: ndc)
Generic Name nicotine (source: ndc)
Application Number ANDA074612 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/24h
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (76282-781-40) / 1 h in 1 POUCH
source: ndc

Packages (1)

76282-781-40 14 POUCH in 1 CARTON (76282-781-40) / 1 h in 1 POUCH

Ingredients (1)

nicotine (7 mg/24h)

Linked Drug Pages (1)

Nicotine Transdermal System ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "2aec5dc5-7c75-43f4-b724-de29ac1f84cb", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198029", "198030", "198031"], "spl_set_id": ["5aeb4f5c-7cc4-4532-b76e-53bdee8e7220"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["EXELAN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (76282-781-40)  / 1 h in 1 POUCH", "package_ndc": "76282-781-40", "marketing_start_date": "20251013"}], "brand_name": "Nicotine Transdermal System", "product_id": "76282-781_2aec5dc5-7c75-43f4-b724-de29ac1f84cb", "dosage_form": "FILM, EXTENDED RELEASE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "76282-781", "generic_name": "Nicotine", "labeler_name": "EXELAN PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Transdermal System", "active_ingredients": [{"name": "NICOTINE", "strength": "7 mg/24h"}], "application_number": "ANDA074612", "marketing_category": "ANDA", "marketing_start_date": "20251013", "listing_expiration_date": "20261231"}