donepezil hydrochloride
- Product NDC
- 68382-346
- 11-digit product format
- 683820346
- Labeler code
- 68382
- Product ID
- 68382-346_8c8f4e5f-acf1-443f-a890-6665c7cc9aa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- donepezil hydrochloride
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA090175
- Marketing category
- ANDA
- Marketing start
- 2011-05-11
- Marketing end
- 0000-00-00
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-346-01 | 68382034601 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-01) | | 2011-05-11 | 0000-00-00 | No | No | Current |
| 68382-346-05 | 68382034605 | 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-05) | | 2011-05-11 | 0000-00-00 | No | No | Current |
| 68382-346-06 | 68382034606 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-06) | | 2011-05-11 | 0000-00-00 | No | No | Current |
| 68382-346-10 | 68382034610 | 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-10) | | 2011-05-11 | 0000-00-00 | No | No | Current |
| 68382-346-16 | 68382034616 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-16) | | 2011-05-11 | 0000-00-00 | No | No | Current |
| 68382-346-77 | 68382034677 | 100 BLISTER PACK in 1 CARTON (68382-346-77) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-346-30) | 100 blister pack | 2011-05-11 | 0000-00-00 | No | No | Current |