Donepezil hydrochloride
- Product NDC
- 55111-357
- 11-digit product format
- 551110357
- Labeler code
- 55111
- Product ID
- 55111-357_d6af4584-b379-0cea-78b6-a493f88708c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Limited
- Application
- ANDA201001
- 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 |
|---|
| 55111-357-05 | Donepezil hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
| 55111-357-10 | Donepezil hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
| 55111-357-30 | Donepezil hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 55111-357-78 | Donepezil hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 11 |
| 55111-357-79 | Donepezil hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 11 |
| 55111-357-90 | Donepezil hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 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 [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| Donepezil | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-357 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 11 | Current NDC, Legacy NDC, 6 package rows | 20241222_4c9889fd-2cb3-02da-f034-46120acc38c3.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 |
|---|
| 55111-357-05 | 55111035705 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-357-05) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 55111-357-10 | 55111035710 | 1000 TABLET, FILM COATED in 1 BOTTLE (55111-357-10) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 55111-357-30 | 55111035730 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-357-30) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 55111-357-78 | 55111035778 | 10 BLISTER PACK in 1 CARTON (55111-357-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-357-79) | 10 blister pack | 2011-05-31 | 0000-00-00 | No | No | Current |
| 55111-357-79 | 55111035779 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 55111-357-90 | 55111035790 | 90 TABLET, FILM COATED in 1 BOTTLE (55111-357-90) | | 2011-05-31 | 0000-00-00 | No | No | Current |