Prescription drug · ANDA
Donepezil (donepezil hydrochloride) NDC 70518-4380
Donepezil hydrochloride 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4380-0 | 70518438000 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4380-0)Marketed from Jul 1, 2025 |
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
- Generic name (nonproprietary)
- donepezil hydrochloride
- Active ingredients
- Donepezil hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203034
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4380_5b0ed35a-9262-1c6f-e063-6394a90a01d2SPL ID 5b0ed35a-9262-1c6f-e063-6394a90a01d2SPL set ID 37fc6638-4a63-4582-a64c-3525f8ed7ef2RxCUI 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
N470518438000followed by a unit qualifier and the quantityPackage 70518-4380-00. 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 hydrochloride tablet, 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.
Other NDCs under ANDA 203034
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 |
|---|---|---|---|---|
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-119 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-120 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-303 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-292 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2627 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-738 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-737 |