Donepezil
- Product NDC
- 70518-4380
- 11-digit product format
- 705184380
- Labeler code
- 70518
- Product ID
- 70518-4380_38f267b8-b95d-f393-e063-6294a90ad5be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203034
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3O2T2PJ89D | DONEPEZIL HYDROCHLORIDE | 120011-70-3 | DONEPEZIL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4380-0 | 70518438000 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4380-0) | 90 tablet | 2025-07-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Donepezil | REMEDYREPACK INC. | 2025-07-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |