Over-the-counter drug · ANDA
Nicotine Transdermal System (Nicotine) NDC 76282-782
Nicotine 14 mg/24h · Film, Extended release · Transdermal · EXELAN PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-782-40 | 7628207824076282078240 | 14 POUCH in 1 CARTON (76282-782-40) / 1 h in 1 POUCHMarketed from Oct 13, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nicotine Transdermal System
- Generic name (nonproprietary)
- nicotine
- Active ingredients
- Nicotine — 14 mg/24h
- Dosage form
- Film, Extended release
- Route
- Transdermal
- Labeler
- EXELAN PHARMACEUTICALS, INC.NDC labeler code 76282
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074612
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 76282-782_2aec5dc5-7c75-43f4-b724-de29ac1f84cbSPL ID 2aec5dc5-7c75-43f4-b724-de29ac1f84cbSPL set ID 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220RxCUI 198029, 198030, 198031UNII 6M3C89ZY6R
- Pharmacologic class
- Cholinergic Nicotinic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476282078240followed by a unit qualifier and the quantityPackage 76282-0782-40. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
Excerpt only. Read the full label for complete information.
About NDC 76282-782
- What is NDC 76282-782?
- 76282-782 is the product NDC for Nicotine Transdermal System (nicotine), Nicotine 14 mg/24h film, extended release, listed with the FDA by EXELAN PHARMACEUTICALS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine Transdermal System (Nicotine).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- EXELAN PHARMACEUTICALS, INC., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nicotine Transdermal System?
- 42 other product NDCs are listed under this name. See all Nicotine Transdermal System NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Transdermal System products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotine Transdermal System | Nicotine 7 mg/24h | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-668 | 50742-0668-0750742-0668-14 |
| Nicotine Transdermal System | Nicotine 14 mg/24h | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-669 | 50742-0669-0750742-0669-1450742-0669-28 |
| Nicotine Transdermal System | Nicotine 21 mg/24h | PatchTransdermal | Ingenus Pharmaceuticals, LLC | 50742-670 | 50742-0670-0750742-0670-1450742-0670-28 |
| Nicotine Transdermal System | Nicotine 21 mg/24h | PatchTransdermal | Quitine LLC | 84720-122 | 84720-0122-1484720-0122-28 |
| Nicotine Transdermal System | Nicotine 7 mg/24h | PatchTransdermal | Quitine LLC | 84720-120 | 84720-0120-14 |
| Nicotine Transdermal System | Nicotine 14 mg/24h | PatchTransdermal | Quitine LLC | 84720-121 | 84720-0121-14 |
| Nicotine Transdermal System | Nicotine 14 mg/24h | PatchTransdermal | Aveva Drug Delivery Systems, Inc. | 3215-0121 | 03215-0121-14 |
| Nicotine Transdermal System | Nicotine 7 mg/24h | PatchTransdermal | Aveva Drug Delivery Systems, Inc. | 3215-0120 | 03215-0120-14 |
| Nicotine Transdermal System | Nicotine 21 mg/24h | PatchTransdermal | Aveva Drug Delivery Systems, Inc. | 3215-0122 | 03215-0122-14 |
| Nicotine Transdermal Systemnicotine | Nicotine 7 mg/24h | Film, Extended releaseTransdermal | EXELAN PHARMACEUTICALS, INC. | 76282-781 | 76282-0781-40 |
Other NDCs under ANDA 074612
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| foster and thrive STEP 1nicotine transdermal system | Nicotine 21 mg/24h | PatchTransdermal | Strategic Sourcing Services LLC | 70677-1182 |
| foster and thrive STEP 2nicotine transdermal system | Nicotine 14 mg/24h | PatchTransdermal | Strategic Sourcing Services LLC | 70677-1181 |
| foster and thrive STEP 3nicotine transdermal system | Nicotine 7 mg/24h | PatchTransdermal | Strategic Sourcing Services LLC | 70677-1180 |
| Medlinenicotine | Nicotine 21 mg/1 | PatchTransdermal | Medline Industries, LP | 53329-192 |
| Nicotine | Nicotine 7 mg/24h | PatchTransdermal | Rugby Laboratories | 0536-5894 |
| Nicotine | Nicotine 14 mg/24h | PatchTransdermal | Rugby Laboratories | 0536-5895 |
| Nicotine | Nicotine 21 mg/24h | PatchTransdermal | Rugby Laboratories | 0536-5896 |
| Nicotine | Nicotine 14 mg/24h | PatchTransdermal | A-S Medication Solutions | 50090-1148 |
| Nicotine | Nicotine 7 mg/24h | PatchTransdermal | A-S Medication Solutions | 50090-1694 |
| Nicotine | Nicotine 21 mg/24h | PatchTransdermal | A-S Medication Solutions | 50090-1697 |
| Nicotine | Nicotine 21 mg/24h | PatchTransdermal | Strategic Sourcing Services LLC | 70677-0032 |
| Nicotine | Nicotine 21 mg/24h | PatchTransdermal | Meijer, Inc. | 79481-0052 |
| Nicotine | Nicotine 14 mg/24h | PatchTransdermal | Meijer, Inc. | 79481-0053 |
| Nicotine | Nicotine 7 mg/24h | PatchTransdermal | Meijer, Inc. | 79481-0054 |
| Nicotine Transdermal System | Nicotine 7 mg/24h | Patch, Extended releaseTransdermal | Walgreens | 0363-1243 |
| Nicotine Transdermal System | Nicotine 14 mg/24h | Patch, Extended releaseTransdermal | Walgreens | 0363-1244 |
| Nicotine Transdermal System | Nicotine 21 mg/24h | Patch, Extended releaseTransdermal | Walgreens | 0363-1245 |
| Nicotine Transdermal System | Nicotine 7 mg/24h | PatchTransdermal | Aveva Drug Delivery Systems, Inc. | 3215-0120 |
| Nicotine Transdermal System | Nicotine 14 mg/24h | PatchTransdermal | Aveva Drug Delivery Systems, Inc. | 3215-0121 |
| Nicotine Transdermal System | Nicotine 21 mg/24h | PatchTransdermal | Aveva Drug Delivery Systems, Inc. | 3215-0122 |
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