Prescription drug · NDA
Exelon (Rivastigmine) NDC 0078-0503
Rivastigmine 13.3 mg/24h · Patch, Extended release · Transdermal · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0503-15 | 0007805031500078050315 | 30 PATCH in 1 CARTON (0078-0503-15) / 24 h in 1 PATCH (0078-0503-61)Marketed from Jul 6, 2007 |
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)
- Exelon
- Generic name (nonproprietary)
- rivastigmine
- Active ingredients
- Rivastigmine — 13.3 mg/24h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022083
- Marketing start
- Marketing end
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 0078-0503_9b5555ca-d9a2-4f50-8037-abbf702d0a27SPL ID 9b5555ca-d9a2-4f50-8037-abbf702d0a27SPL set ID 07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0RxCUI 725021, 725023, 725105, 751302, 1308569, 1308571UNII PKI06M3IW0
- Pharmacologic class
- Cholinesterase Inhibitor
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
N400078050315followed by a unit qualifier and the quantityPackage 00078-0503-15. 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)
EXELON PATCH is an acetylcholinesterase inhibitor indicated for treatment of: • Mild, moderate, and severe dementia of the Alzheimer’s type (AD). ( 1.1 ) • Mild-to-moderate dementia associated with Parkinson’s disease (PD). ( 1.2 ) 1.1 Alzheimer’s Disease EXELON PATCH is indicated for the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. 1.2 Parkinson’s Disease Dementia EXELON PATCH is indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PDD).
Excerpt only. Read the full label for complete information.
About NDC 0078-0503
- What is NDC 0078-0503?
- 0078-0503 is the product NDC for Exelon (rivastigmine), Rivastigmine 13.3 mg/24h patch, extended release, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Exelon (Rivastigmine).
- What is the active ingredient?
- Rivastigmine.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Exelon?
- 5 other product NDCs are listed under this name. See all Exelon NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Exelon products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Exelonrivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Novartis Pharmaceuticals Corporation | 0078-0501 | 00078-0501-15 |
| Exelonrivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Novartis Pharmaceuticals Corporation | 0078-0502 | 00078-0502-15 |
| Exelonrivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-142 | 66758-0142-31 |
| Exelonrivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-143 | 66758-0143-31 |
| Exelonrivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-144 | 66758-0144-31 |
Other NDCs under NDA 022083
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 |
|---|---|---|---|---|
| Exelonrivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Novartis Pharmaceuticals Corporation | 0078-0501 |
| Exelonrivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Novartis Pharmaceuticals Corporation | 0078-0502 |
| Exelonrivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-142 |
| Exelonrivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-143 |
| Exelonrivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-144 |
| Rivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 0781-7304 |
| Rivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 0781-7309 |
| Rivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Sandoz Inc | 0781-7313 |