Donepezil Hydrochloride
- Product NDC
- 70518-4392
- 11-digit product format
- 705184392
- Labeler code
- 70518
- Product ID
- 70518-4392_3a0b2193-f0a9-26aa-e063-6294a90a8368
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090056
- Marketing category
- ANDA
- Marketing start
- 2025-07-15
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3O2T2PJ89D |
| Rxcui | 997229 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4392-0 | Donepezil Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4392-0 | 70518439200 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4392-0) | 2025-07-15 | No | No | Current |