Donepezil Hydrochloride
- Product NDC
- 16571-778
- 11-digit product format
- 165710778
- Labeler code
- 16571
- Product ID
- 16571-778_b963d4b7-66f3-47d7-8671-7412d49e6cb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA090056
- Marketing category
- ANDA
- Marketing start
- 2011-05-31
- 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
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 | 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 |
|---|
| 16571-778-03 | Donepezil Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 16571-778-09 | Donepezil Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 16571-778-10 | Donepezil Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
| 16571-778-50 | Donepezil Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-778 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240110_86b0c5a0-ff3c-4840-a4ac-82af922d58bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16571-778-03 | 16571077803 | 30 TABLET, FILM COATED in 1 BOTTLE (16571-778-03) | 2011-05-31 | 0000-00-00 | No | No | Current |
| 16571-778-09 | 16571077809 | 90 TABLET, FILM COATED in 1 BOTTLE (16571-778-09) | 2011-05-31 | 0000-00-00 | No | No | Current |
| 16571-778-10 | 16571077810 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-778-10) | 2011-05-31 | 0000-00-00 | No | No | Current |
| 16571-778-50 | 16571077850 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-778-50) | 2011-05-31 | 0000-00-00 | No | No | Current |