Memantine and Donepezil Hydrochlorides Extended-release
- Product NDC
- 69238-1552
- 11-digit product format
- 692381552
- Labeler code
- 69238
- Product ID
- 69238-1552_acd577e1-312c-4d5a-85b5-bc50ef9de545
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine and Donepezil
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA208328
- Marketing category
- ANDA
- Marketing start
- 2017-02-01
- Substance
- DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
- Active strength
- 10; 7 mg/1; mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Memantine and Donepezil Hydrochlorides Extended-release
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DONEPEZIL HYDROCHLORIDE | 10 mg/1 |
| MEMANTINE HYDROCHLORIDE | 7 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JY0WD0UA60, 3O2T2PJ89D |
| Rxcui | 1599803, 1599805, 1805420, 1805425 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1552-3 | Memantine and Donepezil Hydrochlorides Extended-release | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 16 |
| 69238-1552-9 | Memantine and Donepezil Hydrochlorides Extended-release | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1552 | MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE (MEMANTINE AND DONEPEZIL) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250302_2335950c-be3b-4248-ad04-e9763aee47d2.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 |
|---|
| 69238-1552-3 | 69238155203 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1552-3) | 2017-02-01 | 0000-00-00 | No | No | Current |
| 69238-1552-9 | 69238155209 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1552-9) | 2017-02-01 | 0000-00-00 | No | No | Current |