Donepezil Hydrochloride
- Product NDC
- 46708-296
- 11-digit product format
- 467080296
- Labeler code
- 46708
- Product ID
- 46708-296_f0627628-81b1-4b14-b49d-1e68b350146f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA201724
- Marketing category
- ANDA
- Marketing start
- 2016-01-29
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-296-10 | 2023-02-01 | C162847 | 48780-1 | f386c64a-013f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 |
| 46708-296-30 | 2023-02-01 | C162847 | 48780-1 | f386c64a-013f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 |
| 46708-296-90 | 2023-02-01 | C162847 | 48780-1 | f386c64a-013f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 |
| 46708-296-91 | 2023-02-01 | C162847 | 48780-1 | f386c64a-013f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 |
| 46708-296-10 | 2023-01-30 | C162847 | 48780-1 | f386c64a-013f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 |
| 46708-296-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-013f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 |
| 46708-296-90 | 2023-01-30 | C162847 | 48780-1 | f386c64a-013f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 |
| 46708-296-91 | 2023-01-30 | C162847 | 48780-1 | f386c64a-013f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, 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 |
|---|
| 46708-296-10 | Donepezil Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 3 |
| 46708-296-30 | Donepezil Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 46708-296-90 | Donepezil Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 46708-296-91 | Donepezil Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-296 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230202_bc570682-413b-46fb-a069-c2986884bfce.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 |
|---|
| 46708-296-10 | 46708029610 | 100 TABLET, FILM COATED in 1 CARTON (46708-296-10) | 2016-01-29 | 0000-00-00 | No | No | Current |
| 46708-296-30 | 46708029630 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-296-30) | 2016-01-29 | 0000-00-00 | No | No | Current |
| 46708-296-90 | 46708029690 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-296-90) | 2016-01-29 | 0000-00-00 | No | No | Current |
| 46708-296-91 | 46708029691 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-296-91) | 2016-01-29 | 0000-00-00 | No | No | Current |