Over-the-counter drug · NDA
Nicotine transdermal system step 1 NDC 0536-1108
nicotine · Nicotine 21 mg/24h · Patch, Extended release · Transdermal · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1108-88 | 00536110888 | 14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCHMarketed from Apr 1, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 step 1Suffix: transdermal system step 1
- Generic name (nonproprietary)
- nicotine
- Active ingredients
- Nicotine — 21 mg/24h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Rugby Laboratories
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020076
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0536-1108_6980948c-7698-2b91-3b07-669e4e6ebba5SPL ID 6980948c-7698-2b91-3b07-669e4e6ebba5
- 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
N400536110888followed by a unit qualifier and the quantityPackage 00536-1108-88. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under NDA 020076
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 |
|---|---|---|---|---|
| Nicotine Transdermal Systemnicotine | Nicotine 21 mg/24h | Patch, Extended releaseTransdermal | A-S Medication Solutions | 50090-7936 |
| Habitrol Step 2nicotine transdermal system patch | Nicotine 14 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Laboratories Inc. | 55741-447 |
| Nicotine Transdermalnicotine | — | KitTransdermal | Rite Aid Corporation | 11822-3627 |
| Nicotine transdermal system step 3nicotine | Nicotine 7 mg/24h | Patch, Extended releaseTransdermal | A-S Medication Solutions | 50090-6383 |
| Habitrol Step 3nicotine transdermal system patch | Nicotine 7 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Laboratories Inc. | 55741-446 |
| Habitrol Step 1nicotine transdermal system patch | Nicotine 21 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Laboratories Inc. | 55741-448 |
| nicotine transdermal systemnicotine | — | KitTransdermal | Dr. Reddy's Laboratories Inc. | 55741-449 |
| Nicotine transdermal system step 1nicotine | Nicotine 21 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Laboratories Inc. | 43598-448 |
| Nicotine transdermal system step 3nicotine | Nicotine 7 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Laboratories Inc. | 43598-446 |
| Nicotine transdermal system step 2nicotine | Nicotine 14 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Laboratories Inc. | 43598-447 |
| Nicotine transdermal system step 3nicotine | Nicotine 7 mg/24h | Patch, Extended releaseTransdermal | Rite Aid Corporation | 11822-4973 |
| Nicotine transdermal system step 2nicotine | Nicotine 14 mg/24h | Patch, Extended releaseTransdermal | Rite Aid Corporation | 11822-4974 |
| Nicotine transdermal system step 1nicotine | Nicotine 21 mg/24h | Patch, Extended releaseTransdermal | Rite Aid Corporation | 11822-4975 |
| Nicotine transdermal system step 3nicotine | Nicotine 7 mg/24h | Patch, Extended releaseTransdermal | CVS Pharmacy | 59779-443 |
| Nicotine transdermal system step 1nicotine | Nicotine 21 mg/24h | Patch, Extended releaseTransdermal | CVS Pharmacy | 59779-448 |
| Nicotine transdermal system step 2nicotine | Nicotine 14 mg/24h | Patch, Extended releaseTransdermal | CVS Pharmacy | 59779-445 |
| Nicotine Transdermal System step 3nicotine | Nicotine 7 mg/24h | Patch, Extended releaseTransdermal | AmerisourceBergen Drug Corporation | 46122-831 |
| Nicotine Transdermal System step 2nicotine | Nicotine 14 mg/24h | Patch, Extended releaseTransdermal | AmerisourceBergen Drug Corporation | 46122-832 |
| Nicotine Transdermal System step 1nicotine | Nicotine 21 mg/24h | Patch, Extended releaseTransdermal | AmerisourceBergen Drug Corporation | 46122-833 |
| Nicotine transdermal system step 3nicotine | Nicotine 7 mg/24h | Patch, Extended releaseTransdermal | Golden State Medical Supply, Inc. | 60429-443 |
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