Prescription drug · ANDA
Rivastigmine Transdermal System (rivastigmine) NDC 51991-897
Rivastigmine 4.6 mg/24h · Patch, Extended release · Transdermal · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-897-30 | 51991089730 | 30 POUCH in 1 CARTON (51991-897-30) / 1 PATCH in 1 POUCH (51991-897-99) / 24 h in 1 PATCHMarketed from Dec 19, 2019 |
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)
- Rivastigmine Transdermal System
- Generic name (nonproprietary)
- rivastigmine
- Active ingredients
- Rivastigmine — 4.6 mg/24h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- 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 51991-897_6c0c606b-108e-4837-8533-f485f9e4ee4bSPL ID 6c0c606b-108e-4837-8533-f485f9e4ee4bSPL set ID b201fe68-b5e5-4a6f-8cf1-069543f03e76RxCUI 725021, 725023, 1308569UNII PKI06M3IW0UPC 0351991899303
- 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
N451991089730followed by a unit qualifier and the quantityPackage 51991-0897-30. 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 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 |
| Rivastigmine Transdermal Systemrivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-8807 |