Namenda
- Product NDC
- 68151-5817
- 11-digit product format
- 681515817
- Labeler code
- 68151
- Product ID
- 68151-5817_899dcc94-a2aa-4a1b-b3c6-7c61ed6cd962
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- NDA022525
- Marketing category
- NDA
- Marketing start
- 2011-10-31
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 28 mg/1
- Pharmacologic classes
- NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 94db636e-a074-45fd-8e8d-331920a99436 | Product name | 4 | 20250103 |
| 941773f8-a40e-0684-da08-ff9a143e6368 | Product name | 7 | 20231219 |
| 5b597f00-4538-4686-aa4e-3c60ed3788c8 | Product name | 2 | 20210511 |
| 1836e79a-a4d1-4087-2f2e-f878e8a1fef2 | Product name | 9 | 20151209 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-5817-8 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-06c4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use NAMENDA XR capsules safely and effectively. See full prescribing information for NAMENDA XR capsules. NAMENDA XR (memantine hydrochloride) extended release capsules Initial U.S. Approval: 2003 ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-5817-8 | Namenda XR | 1 in 1 CUP | CAPSULE, EXTENDED RELEASE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-5817 | NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20160304_617dcd31-3215-4dd8-9b6e-d888d3bf30f3.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 996609 | memantine HCl 28 MG 24HR Extended Release Oral Capsule | PSN | 617dcd31-3215-4dd8-9b6e-d888d3bf30f3 | 2 |
| 996611 | Namenda XR 28 MG 24HR Extended Release Oral Capsule | PSN | 617dcd31-3215-4dd8-9b6e-d888d3bf30f3 | 2 |
| 996611 | 24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule [Namenda] | SBD | 617dcd31-3215-4dd8-9b6e-d888d3bf30f3 | 2 |
| 996609 | 24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule | SCD | 617dcd31-3215-4dd8-9b6e-d888d3bf30f3 | 2 |
| 996611 | 24 HR Namenda 28 MG Extended Release Oral Capsule | SY | 617dcd31-3215-4dd8-9b6e-d888d3bf30f3 | 2 |
| 996609 | memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule | SY | 617dcd31-3215-4dd8-9b6e-d888d3bf30f3 | 2 |
| 996611 | Namenda XR 28 MG 24 HR Extended Release Oral Capsule | SY | 617dcd31-3215-4dd8-9b6e-d888d3bf30f3 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-5817-8 | 68151581708 | 1 in 1 CUP | Historical |