Prescription drug · ANDA
Rivastigmine Transdermal System (rivastigmine) NDC 63629-8807
Rivastigmine 9.5 mg/24h · Patch, Extended release · Transdermal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8807-1 | 63629880701 | 30 POUCH in 1 CARTON (63629-8807-1) / 1 PATCH in 1 POUCH (63629-8807-2) / 24 h in 1 PATCHMarketed from Sep 1, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Rivastigmine Transdermal System
- Generic name (nonproprietary)
- rivastigmine
- Active ingredients
- Rivastigmine — 9.5 mg/24h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209063
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-8807_728327eb-6899-4802-a7f2-a68bb7c97c3eSPL ID 728327eb-6899-4802-a7f2-a68bb7c97c3eSPL set ID c569f760-f311-42ba-909c-a36319622b35RxCUI 725023UNII 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
N463629880701followed by a unit qualifier and the quantityPackage 63629-8807-01. 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)
Rivastigmine Transdermal System 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 Rivastigmine Transdermal System 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 Rivastigmine Transdermal System 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.
Other NDCs under ANDA 209063
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 |
|---|---|---|---|---|
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-8846 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Breckenridge Pharmaceutical, Inc. | 51991-897 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Breckenridge Pharmaceutical, Inc. | 51991-898 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Breckenridge Pharmaceutical, Inc. | 51991-899 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 72162-1610 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 72162-1608 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 72162-1609 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-2064 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-2065 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-2066 |