Prescription drug · ANDA
Rivastigmine NDC 16714-116
Rivastigmine 9.5 mg/24h · Patch, Extended release · Transdermal · Northstar Rx LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-116-02 | 16714011602 | 30 POUCH in 1 CARTON (16714-116-02) / 24 h in 1 POUCH (16714-116-01)Marketed from Oct 1, 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
- Generic name (nonproprietary)
- rivastigmine
- Active ingredients
- Rivastigmine — 9.5 mg/24h
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Northstar Rx LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206318
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-116_eb0de734-0cf3-4e83-b14e-feebe76390e0SPL ID eb0de734-0cf3-4e83-b14e-feebe76390e0SPL set ID 8b809739-8381-4cc1-ab4a-5b17ab902a3dRxCUI 725021, 725023, 1308569UNII PKI06M3IW0UPC 0316714115023, 0316714116020, 0316714117027
- 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
N416714011602followed by a unit qualifier and the quantityPackage 16714-0116-02. 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 206318
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 | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1951 |
| Rivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1949 |
| Rivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1950 |
| Rivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1196 |
| Rivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1197 |
| Rivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1198 |
| Rivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Northstar Rx LLC. | 16714-117 |