Donepezil Hydrochloride
- Product NDC
- 67046-1476
- 11-digit product format
- 670461476
- Labeler code
- 67046
- Product ID
- 67046-1476_2d01f6be-2eb0-8f47-e063-6394a90a56af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA090056
- Marketing category
- ANDA
- Marketing start
- 2025-01-31
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1476-3 | 67046147603 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1476-3) | 2025-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Donepezil Hydrochloride | Coupler LLC | Aurobindo Pharma Limited | 2025-01-31 | HUMAN PRESCRIPTION DRUG LABEL | 1 |