donepezil hydrochloride
- Product NDC
- 43547-879
- 11-digit product format
- 435470879
- Labeler code
- 43547
- Product ID
- 43547-879_cd5f4526-14a5-4571-9ef1-f352172dbc44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- donepezil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA200292
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- donepezil hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DONEPEZIL HYDROCHLORIDE | 10 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 |
|---|
| 43547-879-03 | donepezil hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 43547-879-09 | donepezil hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
| 43547-879-11 | donepezil hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-879 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 1 | Current NDC, 3 package rows | 20250429_48178cb4-4fee-47c0-88e9-a4f017f1f448.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43547-879-03 | 43547087903 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-879-03) | 2011-11-01 | No | No | Historical |
| 43547-879-09 | 43547087909 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-879-09) | 2011-11-01 | No | No | Historical |
| 43547-879-11 | 43547087911 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-879-11) | 2011-11-01 | No | No | Historical |