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Nicotine Transdermal System 14 mg/24h Patch, Extended Release, 14 pouches — NDC 46122-0352-74 package photo

Nicotine Transdermal System 14 mg/24h Patch, Extended Release, 14 pouches

by AmerisourceBergen Drug Corporation · 14 POUCH in 1 CARTON (46122-352-74) / 1 h in 1 POUCH
NDC 46122-0352-74
🏷️ FDA NDC (as labeled) 46122-352-74 billing pads the product segment with a zero
OTC Generic 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 →

🆔 Identity & classification

FDA NDC (as labeled) 46122-352-74
Product NDC 46122-352
11-digit billing NDC 46122035274
NCPDP billing unit EA — each (per item)
RxCUI 198029, 198030, 198031
UNII 6M3C89ZY6R
Application # ANDA074612
SPL Set ID 8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-25
Route TRANSDERMAL
Dosage form PATCH, EXTENDED RELEASE
Substance NICOTINE
GPI-14 62100005008530
GPI class GNP 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 46122-352-74 — 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 → 46122-0352-74. 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

LabelerAmerisourceBergen Drug Corporation
Application holderDIFGEN PHARMACEUTICALS LLC
FDA applicationANDA074612 (ANDA)
Labeler code46122
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio37 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.

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

The official label also statesacrylate adhesive, polyester, silicone adhesive

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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $1.814 $25.40 / 14 h
Medicaid paysCMS SDUD · 12 mo $1.74 $24.41 / 14 h
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.814 $1.514
▲ Up 7% over the last 24 months.
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 save 3%
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/24hthis 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/24h 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
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 46122-0352-74, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.3K
Units reimbursed last 4 qtrs
152.7K
Gross reimbursed last 4 qtrs
$266.2K
Avg / prescription
$42.59
Avg / unit
$1.7439
Latest quarter Q4 2025
1.6KRx
Medicaid pays / ea
$1.7439
gross reimbursed
vs
NADAC / ea
$1.8142
acquisition cost
=
Spread
−$0.0703
-4% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
46% FFS 54% MCO
Fee-for-service · 2,901 Rx Managed care · 3,349 Rx
State Medicaid map
Alaska: no data reported AK Maine: 783 units · 56.1 per 100k residents ME Washington: 2,327 units · 29.8 per 100k residents WA Idaho: 2,312 units · 118 per 100k residents ID Montana: no data reported MT North Dakota: 392 units · 50.1 per 100k residents ND Minnesota: 6,375 units · 111 per 100k residents MN Wisconsin: 4,578 units · 77.5 per 100k residents WI Michigan: 14,862 units · 148 per 100k residents MI New York: 16,663 units · 85.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,225 units · 28.9 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,674 units · 83.4 per 100k residents IA Illinois: 2,800 units · 22.3 per 100k residents IL Indiana: 2,066 units · 30.1 per 100k residents IN Ohio: 17,258 units · 146 per 100k residents OH Pennsylvania: 8,530 units · 65.8 per 100k residents PA New Jersey: 5,182 units · 55.8 per 100k residents NJ Massachusetts: 4,667 units · 66.7 per 100k residents MA California: 27,666 units · 71.0 per 100k residents CA Utah: 224 units · 6.6 per 100k residents UT Colorado: no data reported CO Nebraska: 556 units · 28.1 per 100k residents NE Missouri: 3,971 units · 64.1 per 100k residents MO Kentucky: 12,124 units · 268 per 100k residents KY West Virginia: no data reported WV Virginia: 3,309 units · 38.0 per 100k residents VA Maryland: 914 units · 14.8 per 100k residents MD Connecticut: no data reported CT Rhode Island: 364 units · 33.2 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 240 units · 8.2 per 100k residents KS Arkansas: 2,982 units · 97.2 per 100k residents AR Tennessee: 1,363 units · 19.1 per 100k residents TN North Carolina: 3,621 units · 33.4 per 100k residents NC South Carolina: 1,064 units · 19.8 per 100k residents SC Delaware: no data reported DE Oklahoma: 231 units · 5.7 per 100k residents OK Louisiana: 448 units · 9.8 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 583 units · 5.3 per 100k residents GA D.C.: no data reported DC Hawaii: 301 units · 21.0 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
5.3268
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 268 /100k
2 Michigan 148 /100k
3 Ohio 146 /100k
4 Idaho 118 /100k
5 Minnesota 111 /100k
6 Arkansas 97.2 /100k
7 New York 85.1 /100k
8 Iowa 83.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46122-0352-74 You're viewing this 14 POUCH in 1 CARTON (46122-352-74) / 1 h in 1 POUCH 2016-07-20 Active

📄 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 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: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 Step 1 Step 2 Step 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day 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 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 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 the 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 36 words

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

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

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

🧪 Inactive Ingredients 7 words

Inactive ingredients acrylate adhesive, polyester, silicone adhesive

🎯 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 ↗
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.