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Nicotine transdermal system Kit, 56 patches — NDC 43598-0445-56 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nicotine transdermal system Kit, 56 patches — NDC 43598-445-56 (Billing 43598-0445-56)

by Dr. Reddys Laboratories Inc. · 56 PATCH in 1 CARTON / 1 KIT in 1 PATCH

This is a package of 56 patches of Nicotine transdermal system Kit from Dr. Reddys Laboratories Inc., marketed since May 2015 and currently FDA-listed; retail pharmacies pay about $1.38 per patche (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 43598-0445-56
🏷️ FDA NDC (as labeled) 43598-445-56 billing pads the product segment with a zero
This package
Contains56 patches Cost per ea$1.38 NADAC Per package$77.11 / 56 patch Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.50/unit — full pricing hub ↓
Main listing for product 43598-445 · Also comes in: 56 patches 43598-445-28
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 43598-445-56 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
43598 labeler · 445 product · 56 package
Package marketed since
May 14, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
56 EA per package
Barcode (UPC-A, from the NDC)
3 4359844556 4
Medicaid fills, this package
4,497 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-445-56
Product NDC 43598-445
11-digit billing NDC 43598044556
NCPDP billing unit EA — each (per item)
RxCUI 198029, 198030, 198031, 892244
Application # NDA020076
SPL Set ID e2391b29-9bac-fc09-f2a5-a3370bc4e2c3
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-05-14
Route TRANSDERMAL
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 62100005006430
GPI class Nicotine
GCN Seq No 051485
GCN 18772
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 TRANSDERMAL SYSTEM
FDB brand name Nicotine Patch
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 051485
  • GCN: 18772
  • GPI-14 (Medi-Span): 62100005006430
  • HICL (First Databank): 006249
  • AHFS class code: 12:02.00.00
  • RxCUI (RxNorm): 198029
Why two NDCs? The FDA registers this code as 43598-445-56 — 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 → 43598-0445-56. 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.

Clinical

Label name NICOTINE TRANSDERMAL SYSTEM Ingredient Nicotine
📗 Our plain-language guide HelloPharmacist
  • That's a really common concern, and it's worth addressing. Nicotine replacement products do deliver nicotine, but in a much more controlled way — without the tar, carbon monoxide,...
  • What exactly does nicotine replacement do — isn't it just replacing one nicotine habit with another?
  • Yes, it actually does matter. If you typically smoke your first cigarette within 30 minutes of waking up, your nicotine dependence is likely stronger, so you'd use the higher-stren...
  • How do I know which strength to use — and does it matter when I have my first cigarette in the morning?
📖 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.

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 $1.377 $77.11 / 56 patch
Medicaid paysCMS SDUD · 12 mo $1.50 $84.15 / 56 patch
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
Feb 2022 Jan 2026 May 2026 Sep 2026 $1.509 $1.363
▼ Down 8% over the last 13 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
43598-0445-28 43598-445-28 56 PATCH in 1 CARTON / 1 KIT in 1 PATCH — — 2015-05-14 — Active
43598-0445-56 You're viewing this Main listing 56 PATCH in 1 CARTON / 1 KIT in 1 PATCH $1.38 / ea $77.11 2015-05-14 — Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 56 patches — 56 patch in 1 carton / 1 kit in 1 patch.
How does this package differ from NDC 43598-0445-28?
Both are Nicotine transdermal system Kit — the drug itself is identical. This page's package is the 56 patches one, while NDC 43598-0445-28 is the 56 patches package.
What NDC number is used to bill for this package of Nicotine transdermal system Kit?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicotine transdermal systemthis 43598-0445-56 Dr. 56 patches $1.377 — Availability likely —
Nicotine 21 mg/24h 70677-0032-01 Strategic 14 pouches $1.533 — FDA listed +11%
Nicotine 7 mg/24h 70677-0030-01 Strategic 14 pouches $1.597 — Discontinued +16%
Nicotine 14 mg/24h 70677-0031-01 Strategic 14 pouches $1.765 — Discontinued +28%
Nicotine transdermal system step 3 7 mg/24h 00536-1106-88 Rugby 14 patches $1.820 — Availability likely +32%
Nicotine transdermal system step 3 7 mg/24h 70677-1264-01 Strategic 14 patches $1.820 — Availability likely +32%
Nicotine 7 mg/24h 00536-5894-53 Rugby 7 pouches $1.820 — Availability likely +32%
Nicotine Transdermal System 7 mg/24h 76282-0781-40 EXELAN 14 pouches $1.820 — Availability likely +32%
Nicotine transdermal system step 3 7 mg/24h 43598-0446-70 Dr. 7 patches $1.820 — Discontinued +32%
Nicotine Transdermal System step 2 14 mg/24h 70000-0761-01 CARDINAL 7 patches $1.855 — Availability likely +35%
Nicotine transdermal system step 2 14 mg/24h 00536-1107-88 Rugby 14 patches $1.855 — Availability likely +35%
Nicotine Transdermal System 14 mg/24h 76282-0782-40 EXELAN 14 pouches $1.855 — Availability likely +35%
Nicotine transdermal system step 2 14 mg/24h 70677-1265-01 Strategic 14 patches $1.855 — Availability likely +35%
Nicotine transdermal system step 2 14 mg/24h 43598-0447-70 Dr. 7 patches $1.855 — Discontinued +35%
Nicotine 14 mg/24h 00536-5895-53 Rugby 7 pouches $1.855 — Availability likely +35%
Nicotine 21 mg/24h 00536-5896-53 Rugby 7 pouches $1.873 — Availability likely +36%
Nicotine Transdermal System 21 mg/24h 76282-0783-40 EXELAN 14 pouches $1.873 — Availability likely +36%
Nicotine transdermal system step 1 21 mg/24h 43598-0448-28 Dr. 28 patches $1.873 — Discontinued +36%
Nicotine transdermal system step 1 21 mg/24h 70677-1266-01 Strategic 14 patches $1.873 — Availability likely +36%
Nicotine transdermal system step 1 21 mg/24h 00536-1108-88 Rugby 14 patches $1.873 — Availability likely +36%
Nicotine Transdermal System step 1 21 mg/24h 70000-0762-01 CARDINAL 7 patches $1.873 — Availability likely +36%
Nicotine transdermal system step 3 7 mg/24h 50090-6383-00 A-S 14 patches — — FDA listed —
Nicotine 21 mg/24h 79481-0052-01 Meijer, 14 pouches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 11822-4975-00 Rite 7 patches — — FDA listed —
Nicoderm Cq 7 mg/24h 00135-0196-02 Haleon 14 patches — — FDA listed —
Nicotine 14 mg/24h 50090-1148-00 A-S 14 pouches — — FDA listed —
Medline 21 mg 53329-0192-89 Medline 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 59779-0445-70 CVS 7 patches — — Discontinued —
Nicotine Stop Smoking AID 21 mg 87278-0002-01 Guangxi 60 patches — — FDA listed —
Nicotine Stop Smoking AID 14 mg 87278-0007-01 Guangxi 60 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 55910-0313-02 DOLGENCORP, 2 patches — — FDA listed —
Nicotine 7 mg/24h 79481-0054-01 Meijer, 14 pouches — — FDA listed —
GUHIO Nicotine Patch 21 mg 87278-0001-01 Guangxi 42 patches — — FDA listed —
Nicoderm Cq 14 mg/24h 00135-0195-02 Haleon 14 patches — — FDA listed —
Nicotine transdermal system step 3 7 mg/24h 59450-0001-74 The 14 patches — — 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 00363-0455-70 Walgreens 7 patches — — FDA listed —
Stpsmk Quit Smoking Nicotine Patches 28 mg 87231-0001-01 Guangzhou 15 patches — — FDA listed —
Nicotine Transdermal 11822-3627-03 Rite 56 patches — — FDA listed —
Nicotine transdermal system step 3 7 mg/24h 11822-4973-00 Rite 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 11822-4974-00 Rite 14 patches — — FDA listed —
Nicotine transdermal system 7 mg/24h 49035-0196-02 Wal-Mart 14 patches — — FDA listed —
nicotine transdermal system 55741-0449-56 Dr. 56 patches — — Discontinued —
Nicotine transdermal system step 1 21 mg/24h 59450-0003-74 The 14 patches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 63868-0735-14 Chain 14 patches — — FDA listed —
Nicotine transdermal system step 3 7 mg/24h 00363-0451-74 Walgreens 14 patches — — FDA listed —
NWRB Nicotine Transdermal Patch 21 mg 84288-0007-01 Dongkou 30 patches — — FDA listed —
Nicotine Stop Smoking Aid 14 mg 84735-0013-01 Hengyang 30 patches — — Discontinued —
Nicotine Stop Smoking AID 7 mg 87278-0008-01 Guangxi 60 patches — — FDA listed —
Nicotine Stop Smoking AID 21 mg 87278-0009-01 Guangxi 60 patches — — FDA listed —
Medline 14 mg 53329-0191-89 Medline 14 patches — — FDA listed —
Nicotine transdermal system step 3 7 mg/24h 59779-0443-74 CVS 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 60429-0444-14 Golden 14 patches — — FDA listed —
Nicotine transdermal system 21 mg/24h 68196-0194-03 Sam's 21 patches — — Discontinued —
Nicotine 14 mg/24h 79481-0053-01 Meijer, 14 pouches — — FDA listed —
Nicotine Patch 7 mg 87704-0002-01 Guangzhou 30 patches — — FDA listed —
Nicotine 7 mg/24h 50090-1694-00 A-S 14 pouches — — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 59779-0448-02 CVS 2 pouches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 00363-0457-74 Walgreens 14 patches — — FDA listed —
Nicotine Transdermal System step 3 7 mg/24h 70000-0760-01 CARDINAL 7 patches — — FDA listed —
Nicotine Patch 21 mg 87704-0004-01 Guangzhou 30 patches — — FDA listed —
Nicotine transdermal system 14 mg/24h 49035-0195-02 Wal-Mart 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 59450-0002-74 The 14 patches — — FDA listed —
Sielkin QUIT SMOKING NICOTINE PATCHES 14mg 14 mg/g 83364-0016-01 YITONGBADA 30 patches — — FDA listed —
Sefudun Quit Smoking Nicotine Patches 21 mg 83804-0001-01 Shenzhen 30 patches — — FDA listed —
Nicotine Patch 14 mg 87704-0003-01 Guangzhou 30 patches — — FDA listed —
Nicotine transdermal system step 3 7 mg/24h 60429-0443-14 Golden 14 patches — — FDA listed —
Nicotine transdermal system 14 mg/24h 11673-0195-02 Target 14 patches — — FDA listed —
Nicoderm Cq 21 mg/24h 00135-0194-01 Haleon 7 patches — — FDA listed —
Nicotine Transdermal System 21 mg/24h 50090-7936-00 A-S 14 patches — — FDA listed —
Sielkin QUIT SMOKING NICOTINE PATCHES 7 mg/g 83364-0015-01 YITONGBADA 30 patches — — FDA listed —
Sielkin QUIT SMOKING NICOTINE PATCHES 21mg 21 mg/g 83364-0017-01 YITONGBADA 30 patches — — FDA listed —
Nicotine transdermal system 21 mg/24h 11673-0194-01 Target 7 patches — — Discontinued —
Nicotine transdermal system 7 mg/24h 11673-0196-02 Target 14 patches — — 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 —
Medline 7 mg 53329-0193-89 Medline 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 63868-0734-14 Chain 14 patches — — FDA listed —
Nicotine Transdermal System step 3 7 mg/24h 46122-0831-45 AmerisourceBergen 14 patches — — FDA listed —
Nicotine Transdermal System step 2 14 mg/24h 46122-0832-45 AmerisourceBergen 14 patches — — FDA listed —
Nicotine Transdermal System step 1 21 mg/24h 46122-0833-45 AmerisourceBergen 14 patches — — FDA listed —
Nicotine Transdermal System step 3 7 mg/24h 76162-0740-14 Topco 14 patches — — FDA listed —
Nicotine Transdermal System step 2 14 mg/24h 76162-0741-14 Topco 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

🏛️
2015
On the market since
May 2015
📍
2026
Currently FDA-listed
11 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.

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.

🧪 Avoiding an ingredient? See Nicotine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

From the label’s inactive-ingredient sectionAcrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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.

Manufacturer & labeler

LabelerDr. Reddys Laboratories Inc.
Application holderDR REDDYS LABORATORIES SA
FDA applicationNDA020076 (NDA)
Labeler code43598
First marketedMay 2015
Product typeHuman Otc Drug
Portfolio34 products on file

More NDCs from Dr. Reddys Laboratories Inc. labeler code 43598

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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 • stop smoking completely when you begin using the patch • if you smoke more than 10 cigarettes per day, use the following schedule below: STEP 1 STEP 2 STEP 3 Use one 21mg patch/day Use one 14mg patch/day Use one 7mg 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 and then stop • 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 • 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, use nicotine gum, or use another nicotine patch 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. 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

📄 Do Not Use 26 words ▾

Do not use • if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products

📄 Ask a Doctor Before Use If 55 words ▾

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 34 words ▾

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 50 words ▾

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 53 words ▾

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 52 words ▾

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.

📄 Questions or Comments 136 words ▾

Questions or comments? call 1-800-585-8682 Weekdays (9am-8pm ET) or visit us at www.habitrol.com TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2.

Use one patch daily according to directions. 3. It is important to complete treatment.

4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider. 5.

Use patch with a behavioural support program, such as the one described in the enclosed booklet. For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn. • Not for sale to persons under 18 years of age. • Proof of age required. • Not for sale in vending machines or from any source where proof of age cannot be verified.

📄 Package Label / Principal Display Panel 9 words ▾

Principal Display Panel Kit Nicotine Transdermal System PATCH Kit

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
4.5K
Units reimbursed last 4 qtrs
240.4K
Gross reimbursed last 4 qtrs
$361.2K
Avg / prescription
$80.33
Avg / unit
$1.5026
Latest quarter Q1 2026
1.1KRx
Medicaid pays / ea
$1.5026
gross reimbursed
vs
NADAC / ea
$1.3769
acquisition cost
=
Spread
+$0.1257
+9% 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 ⓘ
20% FFS 80% MCO
Fee-for-service · 903 Rx Managed care · 3,594 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 644 units · 10.9 per 100k residents WI Michigan: 11,793 units · 117 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 32,592 units · 770 per 100k residents OR Nevada: 7,654 units · 240 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 8,401 units · 66.9 per 100k residents IL Indiana: 21,878 units · 319 per 100k residents IN Ohio: 17,346 units · 147 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 7,680 units · 82.7 per 100k residents NJ Massachusetts: 7,840 units · 112 per 100k residents MA California: 3,096 units · 7.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 7,728 units · 125 per 100k residents MO Kentucky: 38,785 units · 857 per 100k residents KY West Virginia: 4,928 units · 278 per 100k residents WV Virginia: 11,960 units · 137 per 100k residents VA Maryland: 7,874 units · 127 per 100k residents MD Connecticut: 8,284 units · 229 per 100k residents CT Rhode Island: no data reported RI Arizona: 7,633 units · 103 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 7,647 units · 107 per 100k residents TN North Carolina: 12,940 units · 119 per 100k residents NC South Carolina: 1,822 units · 33.9 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,136 units · 68.6 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 7,430 units · 24.4 per 100k residents TX Florida: 1,316 units · 5.8 per 100k residents FL
Units reimbursed · per 100k residents
5.8857
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 857 /100k
2 Oregon 770 /100k
3 Indiana 319 /100k
4 West Virginia 278 /100k
5 Nevada 240 /100k
6 Connecticut 229 /100k
7 Ohio 147 /100k
8 Virginia 137 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
56 patches this page43598-0445-56 4,497 Rx · $361,234
56 patches43598-0445-28 No Medicaid data
Drug total (last 4 qtrs): 4,497 Rx · 240,407 units · $361,234 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Nicotine transdermal system (this brand).

Top reported reactions

Nausea1,095
Product Adhesion Issue924
Overdose778
Headache773
Foetal Exposure During Pregnancy750
Nicotine Dependence748
Treatment Noncompliance682

Age at onset

Neonate190
Infant20
Child12
Adolescent24
Adult1,404
Elderly559

Reporter sex

16,316 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization4,730
Death1,606
Life-threatening623
Disabling323
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,213 458
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) ✓ Available
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) ✓ Available
“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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Dr. Reddys Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 56 patches (43598-0445-28). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Dr. Reddys Laboratories 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.
← 43598-0440-01 · Dr.Reddys 43598-0446-70 · Dr. →
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.