Donepezil Hydrochloride
- Product NDC
- 0143-9747
- 11-digit product format
- 001439747
- Labeler code
- 0143
- Product ID
- 0143-9747_0285128a-a3be-4e7a-8d83-9db2322cbe26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA090247
- Marketing category
- ANDA
- Marketing start
- 2011-05-28
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9747-09 | Donepezil Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
| 0143-9747-25 | Donepezil Hydrochloride | 100 in 1 BLISTER PACK | TABLET, FILM COATED | 100 | | 6 |
| 0143-9747-30 | Donepezil Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
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 [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| DONEPEZIL | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED | INACTIVE INGREDIENT | QG4MW19XYX | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9747 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.] | 6 | Legacy NDC, 3 package rows | 20190914_fbec890c-214a-4ef1-adf7-22f274328ec6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0143-9747-09 | 00143974709 | 90 in 1 BOTTLE | Historical |
| 0143-9747-25 | 00143974725 | 100 in 1 BLISTER PACK | Historical |
| 0143-9747-30 | 00143974730 | 30 in 1 BOTTLE | Historical |