Nicotine transdermal system step 1 21 mg/24h Patch, Extended Release — NDC 43598-448-28 (Billing 43598-0448-28)
This is a package of Nicotine transdermal system step 1 21 mg/24h Patch, Extended Release from Dr. Reddy's Laboratories Inc., no longer marketed (first marketed May 2015), no longer in the FDA NDC Directory; retail pharmacies pay about $1.87 per unit (NADAC).
NDC database record
One package, one record: these facts belong to NDC 43598-448-28 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 43598 labeler · 448 product · 28 package
- Package marketed since
- Mar 31, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4359844828 2
- Medicaid fills, this package
- 108,479 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
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 016427
- GCN: 03423
- GPI-14 (Medi-Span): 62100005008540
- HICL (First Databank): 006249
- AHFS class code: 12:02.00.00
- RxCUI (RxNorm): 198029
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Cholinergic Nicotinic Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nicotine — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $1.873 | $52.43 / 28 patch |
| Medicaid paysCMS SDUD · 12 mo | $1.65 | $46.09 / 28 patch |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 43598-0448-28 You're viewing this | 28 PATCH in 1 CARTON / 24 h in 1 PATCH | $1.87 / ea | $52.43 | 2019-03-31 | — | Discontinued by firm |
| 43598-0448-70 43598-448-70 | 7 PATCH in 1 CARTON / 24 h in 1 PATCH | $1.87 / ea | $13.11 | 2019-03-31 | — | Discontinued by firm |
| 43598-0448-74 43598-448-74 Main listing | 14 PATCH in 1 CARTON / 24 h in 1 PATCH | $1.87 / ea | $26.22 | 2019-03-31 | — | Discontinued by firm |
This pack has the lowest per-ea cost of the 3 priced pack sizes ($1.87 NADAC).
This pack accounts for about 35% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Nicotine transdermal system step 1 21 mg/24h Patch, Extended Release?
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
| 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 18% |
| Nicotine transdermal system step 1 21 mg/24h 00536-1108-88 | Rugby | 14 patches | $1.873 | — | Availability likely | — |
| Nicotine 21 mg/24h 00536-5896-53 | Rugby | 7 pouches | $1.873 | — | Availability likely | — |
| Nicotine transdermal system step 1 21 mg/24hthis 43598-0448-28 | Dr. | 28 patches | $1.873 | — | Discontinued | — |
| Nicotine Transdermal System 21 mg/24h 46122-0353-74 | AmerisourceBergen | 14 pouches | $1.873 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 46122-0568-03 | AmerisourceBergen | 28 pouches | $1.873 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 50742-0670-07 | Ingenus | 7 pouches | $1.873 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 68001-0434-88 | BluePoint | 7 pouches | $1.873 | — | Availability likely | — |
| Nicotine Transdermal System Patch Step 1 21 mg/24h 68001-0699-88 | BluePoint | 7 patches | $1.873 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 70000-0512-01 | Cardinal | 7 pouches | $1.873 | — | Availability likely | — |
| Nicotine Transdermal System step 1 21 mg/24h 70000-0762-01 | CARDINAL | 7 patches | $1.873 | — | Availability likely | — |
| foster and thrive STEP 1 21 mg/24h 70677-1182-01 | Strategic | 14 pouches | $1.873 | — | Availability likely | — |
| Nicotine transdermal system step 1 21 mg/24h 70677-1266-01 | Strategic | 14 patches | $1.873 | — | Availability likely | — |
| Nicotine Transdermal System 21 mg/24h 76282-0783-40 | EXELAN | 14 pouches | $1.873 | — | 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Dr. Reddy's Laboratories Inc. labeler code 43598
- Nitroglycerin .4 mg Tablet NDC 43598-436-01
- Nitroglycerin .6 mg Tablet NDC 43598-437-01
- Methylphenidate Hydrochloride 36 mg Tablet, Extended Release NDC 43598-440-01
- Nicotine transdermal system Kit NDC 43598-445-28
- Nicotine transdermal system step 3 7 mg/24h Patch, Extended Release NDC 43598-446-70
- Nicotine transdermal system step 2 14 mg/24h Patch, Extended Release NDC 43598-447-70
- Albendazole 200 mg Tablet, Film Coated NDC 43598-452-02
- Dabigatran etexilate 110 mg Capsule NDC 43598-453-60
- Nilotinib 150 mg Capsule NDC 43598-455-46
- Nilotinib 200 mg Capsule NDC 43598-456-46
- Doxycycline 40 mg Capsule NDC 43598-457-30
- sorafenib 200 mg Tablet, Film Coated NDC 43598-458-04
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 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
📄 Ask a Doctor Before Use If ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
Principal Display Panel Nicotine Transdermal System PATCH 21 mg delivered over 24 hours STOP SMOKING AID Includes: Behavior Support Program with self-help guide STEP 1 IF YOU SMOKE MORE THAN 10 CIGARETTES PER DAY: START WITH STEP 1 IF YOU SMOKE 10 OR LESS CIGARETTES PER DAY: START WITH STEP 2
Principal Display Panel Nicotine Transdermal System PATCH 14 mg delivered over 24 hours STOP SMOKING AID Includes: Behavior Support Program with self-help guide STEP 2 IF YOU SMOKE MORE THAN 10 CIGARETTES PER DAY: USE AFTER COMPLETING STEP 1 IF YOU SMOKE 10 OR LESS CIGARETTES PER DAY: START WITH STEP 2
Principal Display Panel Nicotine Transdermal System PATCH 7 mg delivered over 24 hours STOP SMOKING AID Includes: Behavior Support Program with self-help guide STEP 3 FOR USE AFTER COMPLETING STEP 2
Medicaid utilization & spend
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
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 |