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Nicotine transdermal system step 2 14 mg/24h Patch, Extended Release — NDC 60429-0444-14 package photo

Nicotine transdermal system step 2 14 mg/24h Patch, Extended Release

by Golden State Medical Supply, Inc. · 14 PATCH in 1 CARTON (60429-444-14) / 24 h in 1 PATCH
NDC 60429-0444-14
🏷️ FDA NDC (as labeled) 60429-444-14 billing pads the product segment with a zero
OTC Brand On market Non-controlled
🗂️ 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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 60429-444-14
Product NDC 60429-444
11-digit billing NDC 60429044414
NCPDP billing unit EA — each (per item)
RxCUI 198029, 198030, 198031
UNII 6M3C89ZY6R
Application # NDA020076
SPL Set ID 7c83d507-7e8d-496c-bb9d-63abfa25c7a7
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1999-11-12
Route TRANSDERMAL
Dosage form PATCH, EXTENDED RELEASE
Substance NICOTINE
GPI-14 62100005008530
GPI class Nicotine
GCN Seq No 016426
GCN 03422
HICL code 006249
Ingredient (HICL) Nicotine
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J3
Therapeutic class — intermediate (HIC2) Ganglionic Stimulants
HIC3 code J3A
Therapeutic class — specific (HIC3) Smoking Deterrent Agents (Ganglionic Stim,Others)
AHFS code 12:02.00.00
AHFS class Smoking Cessation Agents
FDB label name NICOTINE 14 MG/24HR PATCH
FDB brand name Nicotine Patch
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 60429-444-14 — 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 → 60429-0444-14. 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

LabelerGolden State Medical Supply, Inc.
Application holderDR REDDYS LABORATORIES SA
FDA applicationNDA020076 (NDA)
Labeler code60429
First marketedNov 1999
Product typeHuman Otc Drug
Portfolio661 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

Label name NICOTINE 14 MG/24HR PATCH Ingredient Nicotine
📖 What it is MedlinePlus · NLM

Nicotine skin patches are used to help people stop smoking cigarettes. They provide a source of nicotine that reduces the withdrawal symptoms experienced when smoking is stopped.

Read the full MedlinePlus article ↗
📗 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1CS02G8656
    Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesacrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 14 mg/24h 70677-0031-01 Strategic 14 pouches $1.765 — Discontinued —
Nicotine transdermal system step 2 14 mg/24h 00536-1107-88 Rugby 14 patches $1.814 — Availability likely —
Nicotine 14 mg/24h 00536-5895-53 Rugby 7 pouches $1.814 — Availability likely —
Nicotine transdermal system step 2 14 mg/24h 43598-0447-70 Dr. 7 patches $1.814 — Discontinued —
Nicotine Transdermal System 14 mg/24h 46122-0352-74 AmerisourceBergen 14 pouches $1.814 — Availability likely —
Nicotine Transdermal System 14 mg/24h 50742-0669-07 Ingenus 7 pouches $1.814 — Availability likely —
Nicotine Transdermal System 14 mg/24h 68001-0433-88 BluePoint 7 pouches $1.814 — Availability likely —
Nicotine Transdermal System Patch Step 2 14 mg/24h 68001-0698-88 BluePoint 7 patches $1.814 — Availability likely —
Nicotine Transdermal System 14 mg/24h 70000-0511-01 Cardinal 7 pouches $1.814 — Availability likely —
Nicotine Transdermal System step 2 14 mg/24h 70000-0761-01 CARDINAL 7 patches $1.814 — Availability likely —
foster and thrive STEP 2 14 mg/24h 70677-1181-01 Strategic 14 pouches $1.814 — Availability likely —
Nicotine transdermal system step 2 14 mg/24h 70677-1265-01 Strategic 14 patches $1.814 — Availability likely —
Nicotine Transdermal System 14 mg/24h 76282-0782-40 EXELAN 14 pouches $1.814 — Availability likely —
Nicoderm Cq 14 mg/24h 00135-0195-02 Haleon 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 00363-0457-74 Walgreens 14 patches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 00363-1244-01 Walgreens 14 pouches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 03215-0121-14 Aveva 14 patches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 03215-1202-07 Aveva 7 pouches — — FDA listed —
Nicotine transdermal system 14 mg/24h 11673-0195-02 Target 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 11822-4974-00 Rite 14 patches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 36800-0034-14 Topco 14 pouches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 37808-0460-01 H-E-B 14 pouches — — FDA listed —
Nicotine transdermal system 14 mg/24h 49035-0195-02 Wal-Mart 14 patches — — FDA listed —
Nicotine 14 mg/24h 50090-1148-00 A-S 14 pouches — — FDA listed —
Medline 14 mg 53329-0191-89 Medline 14 patches — — FDA listed —
Habitrol Step 2 14 mg/24h 55741-0447-70 Dr. 7 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 59450-0002-74 The 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 59779-0445-70 CVS 7 patches — — Discontinued —
Nicotine transdermal system step 2 14 mg/24hthis 60429-0444-14 Golden 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 63868-0734-14 Chain 14 patches — — FDA listed —
Nicotine 14 mg/24h 79481-0053-01 Meijer, 14 pouches — — FDA listed —
Sielkin QUIT SMOKING NICOTINE PATCHES 14mg 14 mg/g 83364-0016-01 YITONGBADA 30 patches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 84720-0121-14 Quitine 14 patches — — FDA listed —
Nicotine Stop Smoking Aid 14 mg 84735-0013-01 Hengyang 30 patches — — Discontinued —
Rstrvbr QUIT SMOKING 14 mg/1001 85248-0131-01 Jiangxi 30 patches — — FDA listed —
Nicotine Patches 14 mg/14mg 85333-0004-02 Zhejiang 14 patches — — FDA listed —
WOFANLI Quit Smoking Nicotine Patches 14 mg/1001 85835-0005-01 Shenzhen 30 patches — — FDA listed —
WOFANLI Quit Smoking Nicotine Patches 14 mg/1001 85835-0008-01 Shenzhen 15 patches — — FDA listed —
NicDuic Quit Smoking Nicotine Patches 2 Step 14 mg/1001 85835-0011-01 Shenzhen 30 patches — — FDA listed —
NicDuic Quit Smoking Nicotine Patches 1-3 Step 14 mg/1001 85835-0014-01 Shenzhen 15 patches — — FDA listed —
Nicotine Stop Smoking AID 14 mg 87278-0007-01 Guangxi 60 patches — — FDA listed —
Nicotine Patch 14 mg 87704-0003-01 Guangzhou 30 patches — — FDA listed —
Nicotine Transdermal System step 2 14 mg/24h 46122-0832-45 AmerisourceBergen 14 patches — — FDA listed —
Nicotine Transdermal System step 2 14 mg/24h 76162-0741-14 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

🏛️
1999
On the market since
Nov 1999
📍
2026
Currently FDA-listed
27 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
60429-0444-14 You're viewing this 14 PATCH in 1 CARTON (60429-444-14) / 24 h in 1 PATCH 2015-09-23 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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 ✓ Available
Inactive ingredients (structured) ✓ 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.
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 60429-444-14, 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: 60429-0444-14, written without dashes as 60429044414. 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 60429-0444-14, the first segment (60429) is the labeler code FDA assigned to Golden State Medical Supply, Inc.; the middle segment (0444) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Golden State Medical Supply, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Golden State Medical Supply, 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 ~1 min read ▾

Directions if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed self-help guide for complete directions and other information begin using the patch on your quit day if you smoke more than 10 cigarettes per day, use the following schedule below: 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 1-4 Weeks 5-6 Weeks 7-8 if you smoke 10 or less cigarettes per day , start with Step 2 for 6 weeks, then Step 3 for 2 weeks apply one new patch every 24 hours on skin that is dry, clean and hairless remove backing from patch and immediately press onto skin.

Hold for 10 seconds. wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. the used patch should be removed and a new one applied to a different skin site at the same time each day if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning 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 to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures It is important to complete treatment.

If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

⚠️ Warnings ~1 min read ▾

WARNINGS SECTION 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. 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. • stomach ulcer or diabetes.history of seizures.

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 •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. •you have symptoms of an allergic reaction (such as difficulty breathing or rash).

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. • Save pouch to use for patch disposal. • Dispose of the used patches by folding sticky ends together and putting in pouch.

🧪 Active Ingredient 42 words ▾

Active ingredient Step 1 (in each patch) Nicotine, 21 mg delivered over 24 hours

Active ingredient Step 2 (in each patch) Nicotine, 14 mg delivered over 24 hours

Active ingredient Step 3 (in each patch) Nicotine, 7 mg delivered over 24 hours

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

🎯 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 ↗
← 60429-0443-14 · Golden 60429-0445-14 · Golden →
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.