donepezil hydrochloride
- Product NDC
- 65841-749
- 11-digit product format
- 658410749
- Labeler code
- 65841
- Product ID
- 65841-749_3ca60c78-2542-4158-ab90-ad32d5271bd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- donepezil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA090100
- Marketing category
- ANDA
- Marketing start
- 2011-05-25
- 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
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DONEPEZIL HYDROCHLORIDE | ACTIVE INGREDIENT | 3O2T2PJ89D | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| DONEPEZIL | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-749 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 5 | Legacy NDC | 20221109_43a18848-fb43-4adb-9273-a3fe812e3d05.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-749-01 | 65841074901 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-749-01) | | 2011-05-25 | 0000-00-00 | No | No | Current |
| 65841-749-05 | 65841074905 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-749-05) | | 2011-05-25 | 0000-00-00 | No | No | Current |
| 65841-749-06 | 65841074906 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-749-06) | | 2011-05-25 | 0000-00-00 | No | No | Current |
| 65841-749-10 | 65841074910 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-749-10) | | 2011-05-25 | 0000-00-00 | No | No | Current |
| 65841-749-16 | 65841074916 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-749-16) | | 2011-05-25 | 0000-00-00 | No | No | Current |
| 65841-749-30 | 65841074930 | 10 BLISTER PACK in 1 CARTON (65841-749-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2011-05-25 | 0000-00-00 | No | No | Current |