Donepezil Hydrochloride
- Product NDC
- 46708-296
- 11-digit product format
- 467080296
- Labeler code
- 46708
- Product ID
- 46708-296_f0627628-81b1-4b14-b49d-1e68b350146f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA201724
- Marketing category
- ANDA
- Marketing start
- 2016-01-29
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 10 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-296-10 | 46708029610 | 100 TABLET, FILM COATED in 1 CARTON (46708-296-10) | 2016-01-29 | No | No | Historical |
| 46708-296-30 | 46708029630 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-296-30) | 2016-01-29 | No | No | Historical |
| 46708-296-90 | 46708029690 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-296-90) | 2016-01-29 | No | No | Historical |
| 46708-296-91 | 46708029691 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-296-91) | 2016-01-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Donepezil Hydrochloride | Alembic Pharmaceuticals Limited | 2023-01-27 | Human Prescription Drug Label | 3 |