Donepezil
- Product NDC
- 82009-119
- 11-digit product format
- 820090119
- Labeler code
- 82009
- Product ID
- 82009-119_4533e92e-9af5-cce3-e063-6294a90ac926
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA203034
- Marketing category
- ANDA
- Marketing start
- 2023-07-19
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Donepezil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DONEPEZIL HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3O2T2PJ89D |
| Rxcui | 997223, 997229 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-119-05 | Donepezil | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
| 82009-119-10 | Donepezil | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-119 | DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC] | 1 | Current NDC, 2 package rows | 20230719_c7e1f642-1bdc-4ed6-9b9e-c1af40b926cd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-119-05 | 82009011905 | 500 TABLET in 1 BOTTLE (82009-119-05) | 500 tablet | 2023-07-19 | No | No | Current |
| 82009-119-10 | 82009011910 | 1000 in 1 BOTTLE | | | | | Historical |