Memantine Hydrochloride
- Product NDC
- 54838-221
- 11-digit product format
- 548380221
- Labeler code
- 54838
- Product ID
- 54838-221_7fd7dbb6-a186-4b03-90f2-f76e6f4c0c41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Silarx Pharmaceuticals, Inc.
- Application
- ANDA207236
- Marketing category
- ANDA
- Marketing start
- 2016-11-10
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54838-221-06 | 2024-03-27 | C162847 | 48780-1 | 9d75b9d0-18c4-f424-e053-dadaa90a57ce | 2d5dcee8-8028-4131-ad64-de5bd6384036 |
| 54838-221-13 | 2024-03-27 | C162847 | 48780-1 | 9d75b9d0-18c4-f424-e053-dadaa90a57ce | 2d5dcee8-8028-4131-ad64-de5bd6384036 |
| 54838-221-52 | 2024-03-27 | C162847 | 48780-1 | 9d75b9d0-18c4-f424-e053-dadaa90a57ce | 2d5dcee8-8028-4131-ad64-de5bd6384036 |
| 54838-221-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-18c4-f424-e053-dadaa90a57ce | 2d5dcee8-8028-4131-ad64-de5bd6384036 |
| 54838-221-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-18c4-f424-e053-dadaa90a57ce | 2d5dcee8-8028-4131-ad64-de5bd6384036 |
| 54838-221-52 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-18c4-f424-e053-dadaa90a57ce | 2d5dcee8-8028-4131-ad64-de5bd6384036 |