Donepezil Hydrochloride
- Product NDC
- 65862-326
- 11-digit product format
- 658620326
- Labeler code
- 65862
- Product ID
- 65862-326_3c956648-d46c-41e2-a2d9-8560846a7a32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA090056
- Marketing category
- ANDA
- Marketing start
- 2011-05-31
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-326-01 | Donepezil Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 65862-326-05 | Donepezil Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 65862-326-14 | Donepezil Hydrochloride | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 11 |
| 65862-326-14 | Donepezil Hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 11 |
| 65862-326-30 | Donepezil Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 65862-326-90 | Donepezil Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 11 |
| 65862-326-99 | Donepezil Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
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 [AUROBINDO PHARMA LIMITED] | 6 | |
| DONEPEZIL | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-326 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | Current NDC, Legacy NDC, 7 package rows | 20240109_3257494f-8f44-4978-b92d-bde87b2444b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-326-01 | 65862032601 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-326-01) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 65862-326-05 | 65862032605 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-326-05) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 65862-326-14 | 65862032614 | 10 BLISTER PACK in 1 CARTON (65862-326-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2011-05-31 | 0000-00-00 | No | No | Current |
| 65862-326-30 | 65862032630 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-326-30) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 65862-326-90 | 65862032690 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-326-90) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 65862-326-99 | 65862032699 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-326-99) | | 2011-05-31 | 0000-00-00 | No | No | Current |