Donepezil Hydrochloride
- Product NDC
- 42543-703
- 11-digit product format
- 425430703
- Labeler code
- 42543
- Product ID
- 42543-703_a73d19f0-cd8e-4b4a-8ded-b9e028305958
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Vensun Pharmaceuticals, Inc.
- Application
- ANDA203907
- Marketing category
- ANDA
- Marketing start
- 2014-12-10
- Marketing end
- 0000-00-00
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 42543-703-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e4e9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 |
| 42543-703-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e4e9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 |
| 42543-703-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e4e9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 |
| 42543-703-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e4e9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 |
| 42543-703-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e4e9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE tablets, safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE tablets. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42543-703-01 | Donepezil Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 42543-703-05 | Donepezil Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 42543-703-10 | Donepezil Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
| 42543-703-30 | Donepezil Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 42543-703-90 | Donepezil Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
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 [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| DONEPEZIL | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42543-703 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC.] | 9 | Legacy NDC, 5 package rows | 20180120_851107e7-143c-47f3-8168-1bf197b91c1e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 42543-703-01 | 42543070301 | 100 in 1 BOTTLE | Historical |
| 42543-703-05 | 42543070305 | 500 in 1 BOTTLE | Historical |
| 42543-703-10 | 42543070310 | 1000 in 1 BOTTLE | Historical |
| 42543-703-30 | 42543070330 | 30 in 1 BOTTLE | Historical |
| 42543-703-90 | 42543070390 | 90 in 1 BOTTLE | Historical |