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Nicotine transdermal system 21 mg/24h Patch, Extended Release

by Sam's West Inc · 21 PATCH in 1 CARTON (68196-194-03) / 24 h in 1 PATCH
NDC 68196-0194-03
🏷️ FDA NDC (as labeled) 68196-194-03 billing pads the product segment with a zero
OTC Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Nicotine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · May 14, 2026 — Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. (AVEVA Drug Delivery Systems, Inc.) · FDA recall D-0550-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 68196-194-03
Product NDC 68196-194
11-digit billing NDC 68196019403
RxCUI 198030
UNII 6M3C89ZY6R
Application # NDA020165
SPL Set ID cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2012-03-02
Route TRANSDERMAL
Dosage form PATCH, EXTENDED RELEASE
Substance NICOTINE
Why two NDCs? The FDA registers this code as 68196-194-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68196-0194-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Cholinergic Nicotinic Agonist class.

Pharmacologic class Cholinergic Nicotinic Agonist
Drug family (ATC) Drugs used in nicotine dependence
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSam's West Inc
Application holderCHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
FDA applicationNDA020165 (NDA)
Labeler code68196
First marketedMar 2012
Product typeHuman Otc Drug
Portfolio58 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's a fair question. Nicotine is what makes cigarettes addictive, and it does raise your heart rate and blood pressure. But it's the thousands of other chemicals in cigarette smok...
  • Is nicotine replacement actually safe — isn't nicotine the thing that's bad for you?
  • It comes down to one simple question: when do you smoke your first cigarette of the day? If it's within 30 minutes of waking up, you're a heavier, more dependent smoker and you'll...
  • It depends on the form you're using. With the gum or lozenge, hiccups, heartburn, and a tingling in the mouth are pretty common — these usually mean you're using it a bit too fast....
📖 Read our full Nicotine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicotine 21 mg/24h 70677-0032-01 Strategic 14 pouches $1.533 — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 00536-1108-88 Rugby 14 patches $1.756 — Availability likely —
Nicotine 21 mg/24h 00536-5896-53 Rugby 7 pouches $1.756 — Availability likely —
Nicotine transdermal system step 1 21 mg/24h 43598-0448-28 Dr. 28 patches $1.756 — Discontinued —
Nicotine Transdermal System 21 mg/24h 46122-0353-74 AmerisourceBergen 14 pouches $1.756 — Availability likely —
Nicotine Transdermal System 21 mg/24h 46122-0568-03 AmerisourceBergen 28 pouches $1.756 — Availability likely —
Nicotine Transdermal System 21 mg/24h 50742-0670-07 Ingenus 7 pouches $1.756 — Availability likely —
Nicotine Transdermal System 21 mg/24h 68001-0434-88 BluePoint 7 pouches $1.756 — Availability likely —
Nicotine Transdermal System Patch Step 1 21 mg/24h 68001-0699-88 BluePoint 7 patches $1.756 — Availability likely —
Nicotine Transdermal System 21 mg/24h 70000-0512-01 Cardinal 7 pouches $1.756 — Availability likely —
Nicotine Transdermal System step 1 21 mg/24h 70000-0762-01 CARDINAL 7 patches $1.756 — Availability likely —
foster and thrive STEP 1 21 mg/24h 70677-1182-01 Strategic 14 pouches $1.756 — Availability likely —
Nicotine transdermal system step 1 21 mg/24h 70677-1266-01 Strategic 14 patches $1.756 — Availability likely —
Nicotine Transdermal System 21 mg/24h 76282-0783-40 EXELAN 14 pouches $1.756 — Availability likely —
Nicoderm Cq 21 mg/24h 00135-0194-01 Haleon 7 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 00363-0455-70 Walgreens 7 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 00363-1245-01 Walgreens 14 pouches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 03215-0122-14 Aveva 14 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 03215-1203-07 Aveva 7 pouches — — FDA listed —
Nicotine transdermal system 21 mg/24h 11673-0194-01 Target 7 patches — — Discontinued —
Nicotine transdermal system step 1 21 mg/24h 11822-4975-00 Rite 7 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 36800-0038-14 Topco 14 pouches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 37808-0461-01 H-E-B 14 pouches — — FDA listed —
Nicotine transdermal system 21 mg/24h 49035-0194-01 Wal-Mart 7 patches — — FDA listed —
Nicotine 21 mg/24h 50090-1697-00 A-S 14 pouches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 50090-7936-00 A-S 14 patches — — FDA listed —
Medline 21 mg 53329-0192-89 Medline 14 patches — — FDA listed —
Habitrol Step 1 21 mg/24h 55741-0448-28 Dr. 28 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 55910-0313-02 DOLGENCORP, 2 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 59450-0003-74 The 14 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 59779-0448-02 CVS 2 pouches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 60429-0445-14 Golden 14 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 63868-0735-14 Chain 14 patches — — FDA listed —
Nicotine 21 mg/24h 79481-0052-01 Meijer, 14 pouches — — FDA listed —
Sielkin QUIT SMOKING NICOTINE PATCHES 21mg 21 mg/g 83364-0017-01 YITONGBADA 30 patches — — FDA listed —
Sefudun Quit Smoking Nicotine Patches 21 mg 83804-0001-01 Shenzhen 30 patches — — FDA listed —
NWRB Nicotine Transdermal Patch 21 mg 84288-0007-01 Dongkou 30 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 84720-0122-14 Quitine 14 patches — — FDA listed —
QUIT SMOKING Proven Patches 21 mg/g 84867-0013-01 Jiashen 30 patches — — FDA listed —
Rstrvbr QUIT SMOKING 21 mg/1001 85248-0130-01 Jiangxi 30 patches — — FDA listed —
Serynth Nicotine Transdermal Stop Smoking Aid 21 mg/1001 85248-0164-01 Jiangxi 21 patches — — FDA listed —
Nicotine Patches 21 mg/21mg 85333-0003-02 Zhejiang 14 patches — — FDA listed —
Nicotine Patches 21 mg/1001 85795-0002-01 Shenzhen 30 patches — — FDA listed —
WOFANLI Quit Smoking Nicotine Patches 21 mg/1001 85835-0004-01 Shenzhen 30 patches — — FDA listed —
WOFANLI Quit Smoking Nicotine Patches 21 mg/1001 85835-0009-01 Shenzhen 30 patches — — FDA listed —
NicDuic Quit Smoking Nicotine Patches 1 Step 21 mg/1001 85835-0012-01 Shenzhen 30 patches — — FDA listed —
NicDuic Quit Smoking Nicotine Patches 1-3 Step 21 mg/1001 85835-0013-01 Shenzhen 30 patches — — FDA listed —
quit smoking patches 21 mg 87135-0001-01 Henan 30 patches — — FDA listed —
GUHIO Nicotine Patch 21 mg 87278-0001-01 Guangxi 42 patches — — FDA listed —
Nicotine Stop Smoking AID 21 mg 87278-0002-01 Guangxi 60 patches — — FDA listed —
Nicotine Stop Smoking AID 21 mg 87278-0009-01 Guangxi 60 patches — — FDA listed —
Hqlsey Quit Smoking Patches 21 mg/1001 87405-0001-01 Hansen 14 patches — — FDA listed —
Nicotine Patch 21 mg 87704-0004-01 Guangzhou 30 patches — — FDA listed —
Nicotine transdermal system 21 mg/24hthis 68196-0194-03 Sam's 21 patches — — Discontinued —
Nicotine Transdermal System step 1 21 mg/24h 46122-0833-45 AmerisourceBergen 14 patches — — FDA listed —
Nicotine Transdermal System step 1 21 mg/24h 76162-0742-14 Topco 14 patches — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2012
On the market since
Mar 2012
📍
2026
Currently FDA-listed
14 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nicotrol Ns (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nicotrol Ns. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.96M
Claims incl. refills
3K
Beneficiaries
1.6K
Spend / beneficiary
$1,189.65
Spend / claim
$656.98
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68196-0194-03 You're viewing this 21 PATCH in 1 CARTON (68196-194-03) / 24 h in 1 PATCH 2012-03-02 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68196-194-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68196-0194-03, written without dashes as 68196019403. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68196-0194-03, the first segment (68196) is the labeler code FDA assigned to Sam's West Inc; the middle segment (0194) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Sam's West Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 11 words ▾

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

⏱️ Dosage and Administration ~2 min read ▾

Directions • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other information • stop smoking completely when you begin using the patch • if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-6 Weeks 7-8 Weeks 9-10 • if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg).

Start with STEP 2 (14mg) , for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop. • steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully. • apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use. • remove backing from patch and immediately press onto skin.

Hold for 10 seconds. • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard.

See enclosed User’s Guide for safety and handling. • you may wear the patch for 16 or 24 hours • if you crave cigarettes when you wake up, wear the patch for 24 hours • if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning • the used patch should be removed and a new one applied to a different skin site at the same time each day • do not wear more than one patch at a time • do not cut patch in half or into smaller pieces • do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours • stop using the patch at the end of 10 weeks.

If you started with STEP 2 , stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.

⚠️ Warnings ~1 min read ▾

Warnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.

This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Do Not Use • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products Ask a doctor before use if you have • heart disease, recent heart attack, or irregular heartbeat.

Nicotine can increase your heart rate. • high blood pressure not controlled with medication. Nicotine can increase your blood pressure. • an allergy to adhesive tape or have skin problems because you are more likely to get rashes. Ask a doctor or pharmacist before use if you are • using a non-nicotine stop smoking drug • taking a prescription medicine for depression or asthma.

Your prescription dose may need to be adjusted. When using this product • do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. • if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if • skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together.

Replace in pouch and discard.

🧪 Active Ingredient 12 words ▾

Active ingredient (in each patch) Nicotine, 21 mg delivered over 24 hours

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68196-0177-61 · SAM'S 68196-0204-20 · SAM'S →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.