Nicotine transdermal system step 1 21 mg/24h Patch, Extended Release
by Dr. Reddy's Laboratories Inc. · 28 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCH
NDC 43598-0448-28
🏷️ FDA NDC (as labeled)
43598-448-28
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $1.65/unit — full pricing hub ↓
OTC
Brand
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ 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 ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2015. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
43598-448-28
Product NDC
43598-448
11-digit billing NDC
43598044828
NCPDP billing unit
EA — each (per item)
UNII
6M3C89ZY6R
Application #
NDA020076
SPL Set ID
3a68eb70-0548-fa6f-8b1c-375e8799f24f
Established class (EPC)
Cholinergic Nicotinic Agonist
Chemical class
Nicotine
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Jun 2015)
Marketing start
2015-05-14
Route
TRANSDERMAL
Dosage form
PATCH, EXTENDED RELEASE
Substance
NICOTINE
GPI-14
62100005008540
GPI class
Nicotine
GCN Seq No
016427
GCN
03423
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 21 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 43598-448-28 — 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 → 43598-0448-28. 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
LabelerDr. Reddy's Laboratories Inc.
Application holderDR REDDYS LABORATORIES SA
FDA applicationNDA020076 (NDA)
Labeler code43598
First marketedMay 2015
Product typeHuman Otc Drug
Portfolio158 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 21 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....
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nicotine — tap one for details:
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.
💬 Questions about Nicotine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 1CS02G8656
Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.
1 inactive ingredient listed in the exact product block matched to this NDC.
The official label also statesacrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.756 | $49.17 / 28 patch |
| Medicaid paysCMS SDUD · 12 mo | $1.65 | $46.25 / 28 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
▲ Up 1% 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nicotine 21 mg/24h 70677-0032-01 | Strategic | 14 pouches | $1.533 | — | FDA listed | save 13% |
| Nicotine transdermal system step 1 21 mg/24h 00536-1108-88 | Rugby | 14 patches | $1.756 | — | Availability likely | — |
| Nicotine 21 mg/24h 00536-5896-53 | Rugby | 7 pouches | $1.756 | — | Availability likely | — |
| Nicotine transdermal system step 1 21 mg/24hthis 43598-0448-28 | Dr. | 28 patches | $1.756 | — | Discontinued | — |
| Nicotine Transdermal System 21 mg/24h 46122-0353-74 | AmerisourceBergen | 14 pouches | $1.756 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 46122-0568-03 | AmerisourceBergen | 28 pouches | $1.756 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 50742-0670-07 | Ingenus | 7 pouches | $1.756 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 68001-0434-88 | BluePoint | 7 pouches | $1.756 | — | Availability likely | — |
| Nicotine Transdermal System Patch Step 1 21 mg/24h 68001-0699-88 | BluePoint | 7 patches | $1.756 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 70000-0512-01 | Cardinal | 7 pouches | $1.756 | — | Availability likely | — |
| Nicotine Transdermal System step 1 21 mg/24h 70000-0762-01 | CARDINAL | 7 patches | $1.756 | — | Availability likely | — |
| foster and thrive STEP 1 21 mg/24h 70677-1182-01 | Strategic | 14 pouches | $1.756 | — | Availability likely | — |
| Nicotine transdermal system step 1 21 mg/24h 70677-1266-01 | Strategic | 14 patches | $1.756 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 76282-0783-40 | EXELAN | 14 pouches | $1.756 | — | Availability likely | — |
| Nicoderm Cq 21 mg/24h 00135-0194-01 | Haleon | 7 patches | — | — | FDA listed | — |
| Nicotine transdermal system step 1 21 mg/24h 00363-0455-70 | Walgreens | 7 patches | — | — | FDA listed | — |
| Nicotine Transdermal System 21 mg/24h 00363-1245-01 | Walgreens | 14 pouches | — | — | FDA listed | — |
| Nicotine Transdermal System 21 mg/24h 03215-0122-14 | Aveva | 14 patches | — | — | FDA listed | — |
| Nicotine Transdermal System 21 mg/24h 03215-1203-07 | Aveva | 7 pouches | — | — | FDA listed | — |
| Nicotine transdermal system 21 mg/24h 11673-0194-01 | Target | 7 patches | — | — | Discontinued | — |
| Nicotine transdermal system step 1 21 mg/24h 11822-4975-00 | Rite | 7 patches | — | — | FDA listed | — |
| Nicotine Transdermal System 21 mg/24h 36800-0038-14 | Topco | 14 pouches | — | — | FDA listed | — |
| Nicotine Transdermal System 21 mg/24h 37808-0461-01 | H-E-B | 14 pouches | — | — | 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 | — |
| Nicotine Transdermal System 21 mg/24h 50090-7936-00 | A-S | 14 patches | — | — | FDA listed | — |
| Medline 21 mg 53329-0192-89 | Medline | 14 patches | — | — | FDA listed | — |
| Habitrol Step 1 21 mg/24h 55741-0448-28 | Dr. | 28 patches | — | — | FDA listed | — |
| Nicotine transdermal system step 1 21 mg/24h 55910-0313-02 | DOLGENCORP, | 2 patches | — | — | FDA listed | — |
| Nicotine transdermal system step 1 21 mg/24h 59450-0003-74 | The | 14 patches | — | — | FDA listed | — |
| Nicotine transdermal system step 1 21 mg/24h 59779-0448-02 | CVS | 2 pouches | — | — | 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 63868-0735-14 | Chain | 14 patches | — | — | FDA listed | — |
| Nicotine 21 mg/24h 79481-0052-01 | Meijer, | 14 pouches | — | — | FDA listed | — |
| Sielkin QUIT SMOKING NICOTINE PATCHES 21mg 21 mg/g 83364-0017-01 | YITONGBADA | 30 patches | — | — | FDA listed | — |
| Sefudun Quit Smoking Nicotine Patches 21 mg 83804-0001-01 | Shenzhen | 30 patches | — | — | FDA listed | — |
| NWRB Nicotine Transdermal Patch 21 mg 84288-0007-01 | Dongkou | 30 patches | — | — | FDA listed | — |
| Nicotine Transdermal System 21 mg/24h 84720-0122-14 | Quitine | 14 patches | — | — | FDA listed | — |
| QUIT SMOKING Proven Patches 21 mg/g 84867-0013-01 | Jiashen | 30 patches | — | — | FDA listed | — |
| Rstrvbr QUIT SMOKING 21 mg/1001 85248-0130-01 | Jiangxi | 30 patches | — | — | FDA listed | — |
| Serynth Nicotine Transdermal Stop Smoking Aid 21 mg/1001 85248-0164-01 | Jiangxi | 21 patches | — | — | FDA listed | — |
| Nicotine Patches 21 mg/21mg 85333-0003-02 | Zhejiang | 14 patches | — | — | FDA listed | — |
| Nicotine Patches 21 mg/1001 85795-0002-01 | Shenzhen | 30 patches | — | — | FDA listed | — |
| WOFANLI Quit Smoking Nicotine Patches 21 mg/1001 85835-0004-01 | Shenzhen | 30 patches | — | — | FDA listed | — |
| WOFANLI Quit Smoking Nicotine Patches 21 mg/1001 85835-0009-01 | Shenzhen | 30 patches | — | — | FDA listed | — |
| NicDuic Quit Smoking Nicotine Patches 1 Step 21 mg/1001 85835-0012-01 | Shenzhen | 30 patches | — | — | FDA listed | — |
| NicDuic Quit Smoking Nicotine Patches 1-3 Step 21 mg/1001 85835-0013-01 | Shenzhen | 30 patches | — | — | FDA listed | — |
| quit smoking patches 21 mg 87135-0001-01 | Henan | 30 patches | — | — | FDA listed | — |
| GUHIO Nicotine Patch 21 mg 87278-0001-01 | Guangxi | 42 patches | — | — | FDA listed | — |
| Nicotine Stop Smoking AID 21 mg 87278-0002-01 | Guangxi | 60 patches | — | — | FDA listed | — |
| Nicotine Stop Smoking AID 21 mg 87278-0009-01 | Guangxi | 60 patches | — | — | FDA listed | — |
| Hqlsey Quit Smoking Patches 21 mg/1001 87405-0001-01 | Hansen | 14 patches | — | — | FDA listed | — |
| Nicotine Patch 21 mg 87704-0004-01 | Guangzhou | 30 patches | — | — | FDA listed | — |
| Nicotine transdermal system 21 mg/24h 68196-0194-03 | Sam's | 21 patches | — | — | Discontinued | — |
| Nicotine Transdermal System step 1 21 mg/24h 46122-0833-45 | AmerisourceBergen | 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.
🗺️ 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 43598-0448-28, 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
109.3K
Units reimbursed last 4 qtrs
3M
Gross reimbursed last 4 qtrs
$4.91M
Avg / prescription
$44.97
Avg / unit
$1.6517
Latest quarter Q4 2025
24.7KRx
Medicaid pays / ea
$1.6517
gross reimbursed
vs
NADAC / ea
$1.7559
acquisition cost
=
Spread
−$0.1042
-6% 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 ⓘ
Fee-for-service · 48,247 Rx Managed care · 61,017 Rx
State Medicaid map
Units reimbursed · per 100k residents
33.93,314
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Drug total (last 4 qtrs): 303,119 Rx · 7,836,102 units · $13,331,803 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 — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 39%
Female · 61%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 43598-0448-28 You're viewing this | 28 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCH | $1.76 / ea | $49.16 | 2019-03-31 | Discontinued by firm |
| 43598-0448-70 | 7 PATCH in 1 CARTON (43598-448-70) / 24 h in 1 PATCH | $1.76 / ea | $12.29 | 2019-03-31 | Discontinued by firm |
| 43598-0448-74 | 14 PATCH in 1 CARTON (43598-448-74) / 24 h in 1 PATCH | $1.76 / ea | $24.58 | 2019-03-31 | Discontinued by firm |
This pack has the lowest per-ea cost of the 3 priced pack sizes ($1.76 NADAC).
This pack accounts for about 36% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 43598-0448-28?
NDC 43598-0448-28 is listed by the FDA — 28 patch in 1 carton / 24 h in 1 patch.
What NDC number is used to bill for this package of Nicotine transdermal system step 1 21 mg/24h Patch, Extended Release?
Bill NDC 43598-0448-28 — the 11-digit billing format is 43598044828. 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.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 43598-448-28, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43598-0448-28, written without dashes as 43598044828. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43598-0448-28, the first segment (43598) is the labeler code FDA assigned to Dr. Reddy's Laboratories Inc.; the middle segment (0448) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (28) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 7 patches (43598-0448-70), 14 patches (43598-0448-74). 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. Reddy's 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.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
⏱️ Dosage and Administration ▾
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 ▾
WARNINGS SECTION If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.
This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have •heart disease, recent heart attack, or irregular heartbeat. • Nicotine can increase your heart rate.high blood pressure not controlled with medication. • Nicotine can increase your blood pressure.an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. • stomach ulcer or diabetes.history of seizures.
Ask a doctor or pharmacist before use if you are •using a non-nicotine stop smoking drug •taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product •if you have vivid dreams or other sleep disturbances remove this patch at bedtime• Stop use and ask a doctor if •skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash •irregular heartbeat or palpitations occur. •you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat. •you have symptoms of an allergic reaction (such as difficulty breathing or rash).
Keep out of reach of children and pets •Used patches have enough nicotine to poison children and pets. • If swallowed, get medical help or contact a Poison Control Center right away. • Save pouch to use for patch disposal. • Dispose of the used patches by folding sticky ends together and putting in pouch.
🧪 Active Ingredient ▾
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 ▾
Inactive ingredients acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer
🎯 Purpose ▾
Purpose Stop smoking aid
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