Donepezil Hydrochloride
- Product NDC
- 0615-8313
- 11-digit product format
- 006158313
- Labeler code
- 0615
- Product ID
- 0615-8313_d950c91f-51cd-4f96-8562-971798db2edf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA201146
- Marketing category
- ANDA
- Marketing start
- 2012-08-17
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8313-05 | Donepezil Hydrochloride | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 17 |
| 0615-8313-28 | Donepezil Hydrochloride | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 17 |
| 0615-8313-30 | Donepezil Hydrochloride | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 17 |
| 0615-8313-30 | Donepezil Hydrochloride | 6 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 6 | | 17 |
| 0615-8313-39 | Donepezil Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8313 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 17 | Current NDC, Legacy NDC, 5 package rows | 20250110_7620f41a-3eef-453b-a564-ea3c85374de2.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 |
|---|
| 0615-8313-05 | 00615831305 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-05) | | 2019-08-21 | 0000-00-00 | No | No | Current |
| 0615-8313-28 | 00615831328 | 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-28) | | 2025-01-06 | | No | No | Historical |
| 0615-8313-30 | 00615831330 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8313-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK | 6 blister pack | 2019-08-19 | 0000-00-00 | No | No | Current |
| 0615-8313-39 | 00615831339 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-39) | | 2019-08-21 | 0000-00-00 | No | No | Current |