donepezil hydrochloride
- Product NDC
- 71335-0900
- 11-digit product format
- 713350900
- Labeler code
- 71335
- Product ID
- 71335-0900_fde8f515-e602-4b77-a4ad-2e829bdaf193
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- donepezil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-0900-1 | donepezil hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 71335-0900-2 | donepezil hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 71335-0900-3 | donepezil hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0900 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 6 | Current NDC, Legacy NDC, 3 package rows | 20231118_c26d9bf3-e148-48bb-8f4f-e8c73804b311.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 |
|---|
| 71335-0900-1 | 71335090001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0900-1) | 2019-10-01 | 0000-00-00 | No | No | Current |
| 71335-0900-2 | 71335090002 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0900-2) | 2022-01-28 | 0000-00-00 | No | No | Current |
| 71335-0900-3 | 71335090003 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0900-3) | 2018-07-12 | 0000-00-00 | No | No | Current |