Donepezil Hydrochloride
- Product NDC
- 69150-416
- 11-digit product format
- 691500416
- Labeler code
- 69150
- Product ID
- 69150-416_4c4bfc6d-a15c-4c6d-93c4-301466517b86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- donepezil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BIOMES PHARMACEUTICALS LLC
- Application
- ANDA090551
- Marketing category
- ANDA
- Marketing start
- 2016-02-25
- Marketing end
- 0000-00-00
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 69150-416-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-012c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets, USP. Donepezil Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1996 |
| 69150-416-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-012c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets, USP. Donepezil Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1996 |
| 69150-416-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-012c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Donepezil Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Donepezil Hydrochloride Tablets, USP. Donepezil Hydrochloride Tablets USP, for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69150-416-03 | Donepezil Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 69150-416-09 | Donepezil Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
| 69150-416-10 | Donepezil Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69150-416 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [BIOMES PHARMACEUTICALS LLC] | 4 | Legacy NDC, 3 package rows | 20180516_cb1809d4-5f84-46bc-830a-f71e8c45bc80.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 69150-416-03 | 69150041603 | 30 in 1 BOTTLE | Historical |
| 69150-416-09 | 69150041609 | 90 in 1 BOTTLE | Historical |
| 69150-416-10 | 69150041610 | 1000 in 1 BOTTLE | Historical |