nicotine transdermal system (68196-194)

Drug Facts

Product Profile

Brand Name nicotine transdermal system

Generic Name nicotine

Labeler sam's west inc

Dosage Form PATCH, EXTENDED RELEASE

Routes

TRANSDERMAL

Active Ingredients

nicotine 21 mg/24h

Manufacturer

Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-194

Product ID 68196-194_0688260f-58f8-41f6-8b77-4e16833f58cc

Product Type HUMAN OTC DRUG

Marketing Category NDA

Application Number NDA020165

Listing Expiration 2026-12-31

Marketing Start 2012-03-02

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68196194

Hyphenated Format 68196-194

Supplemental Identifiers

RxCUI

198030

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 NDA020165 (source: ndc)

Routes

TRANSDERMAL

source: ndc

Resolved Composition

Strengths

21 mg/24h

source: ndc

Packaging

Principal Display Panel NDC 68196-194-03 nicotine patch Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid 21 mg SIMPLY RIGHT ™ Health Care Compare to NicoDerm ® CQ ® * Includes behavior support program enrollment form & user’s guide If you smoke more than 10 cigarettes per day: start with step 1 If you smoke 10 or less cigarettes per day: start with step 2 step 1 21 clear patches ©2011 101775XA 101775XA Nicotine Patch Sams 21 mg 21 ct carton

source: label

Packages (0)

No package records.

Ingredients (1)

nicotine (21 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": "0688260f-58f8-41f6-8b77-4e16833f58cc", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198030"], "spl_set_id": ["cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Nicotine transdermal system", "product_id": "68196-194_0688260f-58f8-41f6-8b77-4e16833f58cc", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68196-194", "generic_name": "nicotine", "labeler_name": "Sam's West Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "brand_name_suffix": "transdermal system", "active_ingredients": [{"name": "NICOTINE", "strength": "21 mg/24h"}], "application_number": "NDA020165", "marketing_category": "NDA", "marketing_start_date": "20120302", "listing_expiration_date": "20261231"}