Prescription drug · ANDA
Rivastigmine Tartrate NDC 65862-650
Rivastigmine tartrate 4.5 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-650-05 | 6586206500565862065005 | 500 CAPSULE in 1 BOTTLE (65862-650-05)Marketed from Mar 25, 2016 | |
| 65862-650-60 | 6586206506065862065060 | 60 CAPSULE in 1 BOTTLE (65862-650-60)Marketed from Mar 25, 2016 | |
| 65862-650-78 | 6586206507865862065078 | 10 BLISTER PACK in 1 CARTON (65862-650-78) / 10 CAPSULE in 1 BLISTER PACK (65862-650-10)Marketed from Mar 25, 2016 |
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 Tartrate
- Generic name (nonproprietary)
- rivastigmine tartrate
- Active ingredients
- Rivastigmine tartrate — 4.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204572
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-650_41507ad1-b7a7-40be-aa24-60a95b60f988SPL ID 41507ad1-b7a7-40be-aa24-60a95b60f988SPL set ID c246a0e5-1e77-41ee-a7b3-384f21f2f2e0RxCUI 312835, 312836, 314214, 314215UNII 9IY2357JPE
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465862065005followed by a unit qualifier and the quantityPackage 65862-0650-05. 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 tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: Mild-to-moderate 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 tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the Alzheimer's type (AD). 1.2 Parkinson’s Disease Dementia Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PD).
Excerpt only. Read the full label for complete information.
About NDC 65862-650
- What is NDC 65862-650?
- 65862-650 is the product NDC for Rivastigmine Tartrate, Rivastigmine tartrate 4.5 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rivastigmine Tartrate.
- What is the active ingredient?
- Rivastigmine tartrate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 Tartrate?
- 36 other product NDCs are listed under this name. See all Rivastigmine Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rivastigmine Tartrate 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 Tartrate | Rivastigmine tartrate 1.5 mg/1 | CapsuleOral | American Health Packaging | 60687-777 | 60687-0777-01 |
| Rivastigmine Tartrate | Rivastigmine tartrate 1.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-063 | 62332-0063-1062332-0063-3062332-0063-60+2 more |
| Rivastigmine Tartrate | Rivastigmine tartrate 3 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-064 | 62332-0064-1062332-0064-3062332-0064-60+2 more |
| Rivastigmine Tartrate | Rivastigmine tartrate 4.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-065 | 62332-0065-1062332-0065-3062332-0065-60+2 more |
| Rivastigmine Tartrate | Rivastigmine tartrate 6 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-066 | 62332-0066-1062332-0066-3062332-0066-60+2 more |
| Rivastigmine Tartrate | Rivastigmine tartrate 1.5 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-011 | 72241-0011-0372241-0011-10 |
| Rivastigmine Tartrate | Rivastigmine tartrate 3 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-012 | 72241-0012-0372241-0012-10 |
| Rivastigmine Tartrate | Rivastigmine tartrate 4.5 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-013 | 72241-0013-0372241-0013-10 |
| Rivastigmine Tartrate | Rivastigmine tartrate 6 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-014 | 72241-0014-0372241-0014-10 |
| Rivastigmine Tartrate | Rivastigmine tartrate 1.5 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-900 | 62135-0900-60 |
Other NDCs under ANDA 204572
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 Tartrate | Rivastigmine tartrate 1.5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7107 |
| Rivastigmine Tartrate | Rivastigmine tartrate 1.5 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-648 |
| Rivastigmine Tartrate | Rivastigmine tartrate 6 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-651 |