Prescription drug · ANDA
Rivastigmine NDC 65162-749
Rivastigmine 13.3 mg/24h · Patch · Transdermal · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-749-34 | 6516207493465162074934 | 30 PATCH in 1 CARTON (65162-749-34) / 24 h in 1 PATCHMarketed from Jun 30, 2015 |
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 — 13.3 mg/24h
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207308
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-749_cf03b1e8-cd2f-44ee-afab-2de64b435b45SPL ID cf03b1e8-cd2f-44ee-afab-2de64b435b45SPL set ID 8b671fc9-8cb0-4406-a9ee-7c95086d6200RxCUI 725021, 725023, 1308569UNII PKI06M3IW0UPC 0365162825343, 0365162826340, 0365162749342
- 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
N465162074934followed by a unit qualifier and the quantityPackage 65162-0749-34. 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.
About NDC 65162-749
- What is NDC 65162-749?
- 65162-749 is the product NDC for Rivastigmine, Rivastigmine 13.3 mg/24h patch, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rivastigmine.
- What is the active ingredient?
- Rivastigmine.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rivastigmine?
- 16 other product NDCs are listed under this name. See all Rivastigmine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rivastigmine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Northstar Rx LLC. | 16714-116 | 16714-0116-02 |
| Rivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Northstar Rx LLC. | 16714-117 | 16714-0117-02 |
| Rivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1196 | 70710-1196-07 |
| Rivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1197 | 70710-1197-07 |
| Rivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1198 | 70710-1198-07 |
| Rivastigmine | Rivastigmine 4.6 mg/24h | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1949 | 70771-1949-07 |
| Rivastigmine | Rivastigmine 9.5 mg/24h | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1950 | 70771-1950-07 |
| Rivastigmine | Rivastigmine 13.3 mg/24h | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1951 | 70771-1951-07 |
| Rivastigmine | Rivastigmine 4.6 mg/24h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9070 | 00378-9070-93 |
| Rivastigmine | Rivastigmine 9.5 mg/24h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-9071 | 00378-9071-93 |
Other NDCs under ANDA 207308
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 4.6 mg/24h | PatchTransdermal | Amneal Pharmaceuticals LLC | 65162-825 |
| Rivastigmine | Rivastigmine 9.5 mg/24h | PatchTransdermal | Amneal Pharmaceuticals LLC | 65162-826 |