Memantine Hydrochloride
- Product NDC
- 43353-165
- 11-digit product format
- 433530165
- Labeler code
- 43353
- Product ID
- 43353-165_bd5eaa03-d2d2-4af4-855f-a3fa51a58b72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA200891
- Marketing category
- ANDA
- Marketing start
- 2015-10-13
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-165 | MEMANTINE HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC | 20171003_7c093eec-e73f-42aa-acef-101e3d6d039e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-165-18 | 43353016518 | 3000 TABLET, COATED in 1 BOTTLE (43353-165-18) | 2016-03-30 | 0000-00-00 | No | No | Current |
| 43353-165-53 | 43353016553 | 60 TABLET, COATED in 1 BOTTLE (43353-165-53) | 2016-03-29 | 0000-00-00 | No | No | Current |