Prescription drug · ANDA
Donepezil Hydrochloride NDC 68788-8711
Donepezil hydrochloride 5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8711-3 | 68788871103 | 30 TABLET in 1 BOTTLE (68788-8711-3)Marketed from Jul 8, 2024 | |
| 68788-8711-6 | 68788871106 | 60 TABLET in 1 BOTTLE (68788-8711-6)Marketed from Jul 8, 2024 | |
| 68788-8711-9 | 68788871109 | 90 TABLET in 1 BOTTLE (68788-8711-9)Marketed from Jul 8, 2024 |
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)
- Donepezil Hydrochloride
- Generic name (nonproprietary)
- donepezil hydrochloride
- Active ingredients
- Donepezil hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078662
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-8711_c9fdb857-2048-40fe-a3d1-4e89dda6cdf4SPL ID c9fdb857-2048-40fe-a3d1-4e89dda6cdf4SPL set ID ee54a472-6783-41df-b8bb-9c3e4c996907RxCUI 997229UNII 3O2T2PJ89D
- 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
N468788871103followed by a unit qualifier and the quantityPackage 68788-8711-03. 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)
Donepezil Hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease (1).
Excerpt only. Read the full label for complete information.