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Nicotine transdermal system step 3 7 mg/24h Patch, Extended Release — NDC 70677-1264-01 package photo

Nicotine transdermal system step 3 7 mg/24h Patch, Extended Release

by Strategic Sourcing Services LLC · 14 PATCH in 1 CARTON (70677-1264-1) / 24 h in 1 PATCH
NDC 70677-1264-01
🏷️ FDA NDC (as labeled) 70677-1264-1 billing pads the package 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 →
⚠️
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) 70677-1264-1
Product NDC 70677-1264
11-digit billing NDC 70677126401
NCPDP billing unit EA — each (per item)
RxCUI 198029, 198030, 198031
UNII 6M3C89ZY6R
Application # NDA020076
SPL Set ID 6c0b5b5c-cc76-6e48-c364-4db0e081557d
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 2015-11-02
Route TRANSDERMAL
Dosage form PATCH, EXTENDED RELEASE
Substance NICOTINE
GPI-14 62100005008520
GCN Seq No 016425
GCN 03421
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 7 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 70677-1264-1 — a 5-4-1 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 package segment → 70677-1264-01. 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

LabelerStrategic Sourcing Services LLC
Application holderDR REDDYS LABORATORIES SA
FDA applicationNDA020076 (NDA)
Labeler code70677
First marketedNov 2015
Product typeHuman Otc Drug
Portfolio316 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 7 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 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 $1.734 $24.27 / 14 patch
Medicaid paysCMS SDUD · 12 mo $1.78 $24.94 / 14 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
Dec 2025 Feb 2026 May 2026 Aug 2026 $1.737 $1.595
▲ Up 9% over the last 9 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 7 mg/24h 70677-0030-01 Strategic 14 pouches $1.597 Discontinued save 8%
Nicotine transdermal system step 3 7 mg/24h 00536-1106-88 Rugby 14 patches $1.733 Availability likely
Nicotine 7 mg/24h 00536-5894-53 Rugby 7 pouches $1.733 Availability likely
Nicotine transdermal system step 3 7 mg/24h 43598-0446-70 Dr. 7 patches $1.733 Discontinued
Nicotine Transdermal System 7 mg/24h 46122-0354-74 AmerisourceBergen 14 pouches $1.733 Availability likely
Nicotine Transdermal System 7 mg/24h 50742-0668-07 Ingenus 7 pouches $1.733 Availability likely
Nicotine Transdermal System 7 mg/24h 68001-0432-88 BluePoint 7 pouches $1.733 Availability likely
Nicotine Transdermal System Patch Step 3 7 mg/24h 68001-0697-88 BluePoint 7 patches $1.733 Availability likely
Nicotine Transdermal System 7 mg/24h 70000-0510-01 Cardinal 7 pouches $1.733 Availability likely
foster and thrive STEP 3 7 mg/24h 70677-1180-01 Strategic 14 patches $1.733 Availability likely
Nicotine transdermal system step 3 7 mg/24hthis 70677-1264-01 Strategic 14 patches $1.733 Availability likely
Nicotine Transdermal System 7 mg/24h 76282-0781-40 EXELAN 14 pouches $1.733 Availability likely
Nicoderm Cq 7 mg/24h 00135-0196-02 Haleon 14 patches FDA listed
Nicotine transdermal system step 3 7 mg/24h 00363-0451-74 Walgreens 14 patches FDA listed
Nicotine Transdermal System 7 mg/24h 00363-1243-01 Walgreens 14 pouches FDA listed
Nicotine Transdermal System 7 mg/24h 03215-0120-14 Aveva 14 patches FDA listed
Nicotine Transdermal System 7 mg/24h 03215-1201-07 Aveva 7 patches FDA listed
Nicotine transdermal system 7 mg/24h 11673-0196-02 Target 14 patches FDA listed
Nicotine transdermal system step 3 7 mg/24h 11822-4973-00 Rite 14 patches FDA listed
Nicotine Transdermal System 7 mg/24h 36800-0032-14 Topco 14 pouches FDA listed
Nicotine transdermal system 7 mg/24h 49035-0196-02 Wal-Mart 14 patches FDA listed
Nicotine 7 mg/24h 50090-1694-00 A-S 14 pouches FDA listed
Nicotine transdermal system step 3 7 mg/24h 50090-6383-00 A-S 14 patches FDA listed
Medline 7 mg 53329-0193-89 Medline 14 patches FDA listed
Habitrol Step 3 7 mg/24h 55741-0446-70 Dr. 7 patches FDA listed
Nicotine transdermal system step 3 7 mg/24h 59450-0001-74 The 14 patches FDA listed
Nicotine transdermal system step 3 7 mg/24h 59779-0443-74 CVS 14 patches FDA listed
Nicotine transdermal system step 3 7 mg/24h 60429-0443-14 Golden 14 patches FDA listed
Nicotine Transdermal System step 3 7 mg/24h 70000-0760-01 CARDINAL 7 patches FDA listed
Nicotine 7 mg/24h 79481-0054-01 Meijer, 14 pouches FDA listed
Sielkin QUIT SMOKING NICOTINE PATCHES 7 mg/g 83364-0015-01 YITONGBADA 30 patches FDA listed
Nicotine Transdermal System 7 mg/24h 84720-0120-14 Quitine 14 patches FDA listed
Rstrvbr QUIT SMOKING 7 mg/1001 85248-0132-01 Jiangxi 30 patches FDA listed
Nicotine Patches 7 mg/7mg 85333-0005-02 Zhejiang 14 patches FDA listed
WOFANLI Quit Smoking Nicotine Patches 7 mg/1001 85835-0006-01 Shenzhen 30 patches FDA listed
WOFANLI Quit Smoking Nicotine Patches 7 mg/1001 85835-0007-01 Shenzhen 15 patches FDA listed
NicDuic Quit Smoking Nicotine Patches 3 Step 7 mg/1001 85835-0010-01 Shenzhen 30 patches FDA listed
NicDuic Quit Smoking Nicotine Patches 1-3 Step 7 mg/1001 85835-0015-01 Shenzhen 15 patches FDA listed
Nicotine Stop Smoking AID 7 mg 87278-0008-01 Guangxi 60 patches FDA listed
Nicotine Patch 7 mg 87704-0002-01 Guangzhou 30 patches FDA listed
Nicotine Transdermal System step 3 7 mg/24h 46122-0831-45 AmerisourceBergen 14 patches FDA listed
Nicotine Transdermal System step 3 7 mg/24h 76162-0740-14 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
Nov 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.

🗺️ 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 70677-1264-01, 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.
📅 Q3 2025 – Q4 2025 · 2 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
223
Units reimbursed last 4 qtrs
4.9K
Gross reimbursed last 4 qtrs
$8.7K
Avg / prescription
$38.96
Avg / unit
$1.7813
Latest quarter Q4 2025
157Rx
Medicaid pays / ea
$1.7813
gross reimbursed
vs
NADAC / ea
$1.7335
acquisition cost
=
Spread
+$0.0478
+3% 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
55% FFS 45% MCO
Fee-for-service · 122 Rx Managed care · 101 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: no data reported WI Michigan: 2,557 units · 25.5 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 882 units · 7.5 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 392 units · 6.3 per 100k residents MO Kentucky: 196 units · 4.3 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 532 units · 8.6 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 318 units · 7.8 per 100k residents OK Louisiana: no data reported 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.325.5
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 Michigan 25.5 /100k
2 Maryland 8.6 /100k
3 Oklahoma 7.8 /100k
4 Ohio 7.5 /100k
5 Missouri 6.3 /100k
6 Kentucky 4.3 /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.

📊 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 step 3 (this brand).

Top reported reactions

Nausea1,095
Product Adhesion Issue929
Overdose779
Headache773
Nicotine Dependence754
Foetal Exposure During Pregnancy750
Treatment Noncompliance684

Age at onset

Neonate190
Infant20
Child12
Adolescent24
Adult1,414
Elderly564

Reporter sex

16,375 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization4,734
Death1,606
Life-threatening623
Disabling323
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,213 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70677-1264-01 You're viewing this 14 PATCH in 1 CARTON (70677-1264-1) / 24 h in 1 PATCH 2025-01-10 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: 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 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 ↗
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.