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RBUGR QUIT SMOKING Nicotine Patches .003 g; .18 g Patch, 60 patches — NDC 87165-0001-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

RBUGR QUIT SMOKING Nicotine Patches .003 g; .18 g Patch, 60 patches — NDC 87165-001-03 (Billing 87165-0001-03)

by Nanjing Ludejin Corporation Management Co., Ltd · 60 PATCH in 1 BOX / 1 PATCH in 1 PATCH

This is a package of 60 patches of RBUGR QUIT SMOKING Nicotine Patches .003 g; .18 g Patch from Nanjing Ludejin Corporation Management Co., Ltd, marketed since Oct 2025 and currently FDA-listed.

NDC 87165-0001-03
🏷️ FDA NDC (as labeled) 87165-001-03 billing pads the product segment with a zero
This package
Contains60 patches Pack sizes3 compare ↓
Product page 87165-0001-01 Also comes in: 21 patches 87165-001-01 42 patches 87165-001-02
OTC 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 87165-001-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87165 labeler · 001 product · 03 package
Package marketed since
Oct 15, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8716500103 6
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) 87165-001-03
Product NDC 87165-001
11-digit billing NDC 87165000103
UNII L7T10EIP3A, 6M3C89ZY6R
Application # 505G(a)(3)
SPL Set ID 412d42c7-d382-20cc-e063-6294a90ae384
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-15
Route TOPICAL
Dosage form PATCH
Substance MENTHOL; NICOTINE
Why two NDCs? The FDA registers this code as 87165-001-03 — 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 → 87165-0001-03. 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.

Clinical

📗 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 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.
Try another pack size: 21 patches 42 patches
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 Marketing startMarketing endStatus
87165-0001-01 87165-001-01 Main listing 21 PATCH in 1 BOX / 1 PATCH in 1 PATCH 2025-10-15 — Active
87165-0001-02 87165-001-02 42 PATCH in 1 BOX / 1 PATCH in 1 PATCH 2025-10-15 — Active
87165-0001-03 You're viewing this 60 PATCH in 1 BOX / 1 PATCH in 1 PATCH 2025-10-15 — Active

Pack size FAQ

What quantity is in this package?
This package contains 60 patches — 60 patch in 1 box / 1 patch in 1 patch.
How does this package differ from NDC 87165-0001-01?
Both are RBUGR QUIT SMOKING Nicotine Patches .003 g; .18 g Patch — the drug itself is identical. This page's package is the 60 patches one, while NDC 87165-0001-01 is the 21 patches package.
What NDC number is used to bill for this package of RBUGR QUIT SMOKING Nicotine Patches .003 g; .18 g Patch?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
RBUGR QUIT SMOKING Nicotine Patches .003 g/1; .18 gthis 87165-0001-03 Nanjing 60 patches — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

💡 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,cellulose paper, methacrylic acid

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.

Manufacturer & labeler

LabelerNanjing Ludejin Corporation Management Co., Ltd
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code87165
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from Nanjing Ludejin Corporation Management Co., Ltd labeler code 87165

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 10 words ▾

USE reduces withdrawal symptoms,including nicotine craving, associated with quitting smoking.

⏱️ Dosage and Administration 109 words ▾

DIRECTIONS If you are under 18 years of age, ask a doctor before use. e Before using this product, read the enclosed self-help guide for complete directions and other information. Begin using the patch on your quit day. o lf you smoke more than 10 cigarettes per day, use the following schedule below. lf you smoke no more than ten cigarettes aday, please start with step 2. Keep your skinclean and dry before each use. lmmediatelyafter removing the adhesive backing, applythe patch to the skin and press the patchagainst the skin for ten seconds to ensure asnug fit.

Wash your hands after each patchapplication and after removing the patchprivately.

⚠️ Warnings 85 words ▾

If you are pregnant or breast-feeding, only use this patch on the advice of your health care provider.Smokina can seriously harm vour child. Try to stop smoking without using any nicotine replacement patch. This product is considered safer than smoking.

However, the risks to your child from this patch are not fully known. The patch is effective in helping to alleviate nicotine cravings. lt is a health supplement to assist in quitting smoking and is not to be used in place of a nicotine patch.

🧪 Active Ingredient 3 words ▾

Nicotine18% menthol 0.3%

🧪 Inactive Ingredients 5 words ▾

acrylate adhesive,cellulose paper, methacrylic acid

🎯 Purpose 3 words ▾

Stop smoking aid

📄 Do Not Use 39 words ▾

If you are allergic to any of the ingredients. e Gastric ulcers or diabetes mellitus, history of seizures prohibited. lf you are under 18 years of age without a doctor's recommendation. Do not use on damaged skin or wounds.

📄 When Using This Product ~1 min read ▾

ASK A DOCTOR BEFORE USE IF YOU HAVE Heart disease,recent heart attack, or irregular heartbeat. , Cardiovascular disorders History ofmyocardial infarction Documented arrhythmias High blood pressure not controlled by medication Stomach ulcer or diabetes Been prescribed medication for depression or asthma Non-tobaccousers or people with skin allergies. WHEN USING THE PATCH if you have vivid dreams or other sleep disturbances, remove this patch at bedtime. e Stop use and aska doctor if feeling uncomfortable or experiencing other sensitive dizziness symptoms. o And followphase recommendations (being adjusted within the recommended range according to your conditionand acceptability). o Do not cut the 7mg patch into halves or smaller pieces.

To avoid possible burns.remove the patch before performing an MRl (Magnetic Resonance lmaging) examination. Adjust thewearing time according to your body weight and your smoking needs it is best to wear the patch formore than 12 hours in order to allow the nicotine in the patch to penetrate completely into the skin, andif you feel uncomfortable, you can use the intermittent patch method, i.e., temporarily remove the patchand put it back on once the discomfort subsides). e The used patch should be removed and a new oneapplied to a different skin site at the same time each day.

Slight dizziness and nausea during use arenormal, please stop using temporarily and drink more water. Reduce the dosage and use it aaainwhen it returns to norma. it is important to complete treatment, if you feel you need to use the patchfor a longer period to keep from smoking, talk to your health care provider. lt is best to remove hairfrom the surface of the skin and keep the skin dry before use for best results. o Drink plenty of waterduring use of the patch to promote absorption and metabolism.

📄 Stop Use and Ask a Doctor If 89 words ▾

you are using a non-nicotine stop smoking drug. Taking a prescription medicine for depression orasthma, your prescription dose may need to be adiusted. o Skin redness caused by the patch does notgo away after 4 days. You develop a rash, swelling, or severe skin irritation.

You experienceirreqular heartbeat or palpitations.o Symptoms of nicotine overdose occur (such as nausea, vomitingdizziness, or weakness). lt is important to complete treatment, if you feel you need to use the patchfor a longer period to keep from smoking, talk to your health care provider.

📄 Keep Out of Reach of Children 46 words ▾

Please store in a cool dry place for best results. (preferably under 20-25°). Keep out of reach ofchildren and pets, Please wrap used patches completely before throwing them away. lf inadvertentlylicked by children or pets, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 1 words ▾

label1

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

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 RBUGR QUIT SMOKING Nicotine Patches (this brand).

Top reported reactions

Nausea1,021
Overdose762
Foetal Exposure During Pregnancy744
Product Adhesion Issue727
Nicotine Dependence715
Headache701
Treatment Noncompliance664

Age at onset

Neonate189
Infant20
Child10
Adolescent24
Adult1,250
Elderly479

Reporter sex

14,919 reports
Male · 43%
Female · 56%
Unknown · 1%

Serious outcomes

Hospitalization4,527
Death1,564
Life-threatening590
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,143 0
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
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 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 Nanjing Ludejin Corporation Management Co., Ltd. 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 2 other package presentations of this same product, including 21 patches (87165-0001-01), 42 patches (87165-0001-02). 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?
Nanjing Ludejin Corporation Management Co., Ltd 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.
← 87163-0920-01 · Ted 87165-0002-01 · Nanjing →
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.