donepezil hydrochloride
- Product NDC
- 43547-276
- 11-digit product format
- 435470276
- Labeler code
- 43547
- Product ID
- 43547-276_dcfd9a94-e1bc-4b53-ae6f-0200ee714917
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- donepezil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA200292
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- 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 |
|---|
| 43547-276-03 | donepezil hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 15 |
| 43547-276-09 | donepezil hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 15 |
| 43547-276-11 | donepezil hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 15 |
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 [SOLCO HEALTHCARE US, LLC] | 3 | |
| donepezil | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| fd&c blue no. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| hydroxypropyl cellulose | INACTIVE INGREDIENT | RFW2ET671P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-276 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20230921_042a59ea-131a-4806-b0f4-2f791d4414e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43547-276-03 | 43547027603 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-03) | 2011-11-01 | 0000-00-00 | No | No | Current |
| 43547-276-09 | 43547027609 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-09) | 2011-11-01 | 0000-00-00 | No | No | Current |
| 43547-276-11 | 43547027611 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-11) | 2011-11-01 | 0000-00-00 | No | No | Current |