Memantine Hydrochloride
- Product NDC
- 47335-322
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090058
- Marketing category
- ANDA
- Substance
- MEMANTINE HYDROCHLORIDE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 47335-322-08 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-322-08) | 20150711 | | No | Historical |
| 47335-322-13 | 500 TABLET, FILM COATED in 1 BOTTLE (47335-322-13) | 20150711 | | No | Historical |
| 47335-322-18 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-322-18) | 20150711 | | No | Historical |
| 47335-322-83 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-322-83) | 20150711 | | No | Historical |
| 47335-322-86 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-322-86) | 20150711 | | No | Historical |
| 47335-322-88 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-322-88) | 20150711 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| 2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929 | These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003 | Bryant Ranch Prepack | 2024-04-05 | HUMAN PRESCRIPTION DRUG LABEL | 102 |
| d1963395-3cf7-4433-bf2c-06295bb1c5b0 | These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2023-10-05 | Human Prescription Drug Label | 13 |
| a2a51c75-d4b2-4735-964c-cb97141edc7a | These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003 | A-S Medication Solutions | 2020-11-16 | Human Prescription Drug Label | 3 |
| 5a455264-1054-2ddb-e053-2991aa0a66b0 | 458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003 | Contract Pharmacy Services-PA | Coupler Enterprises Inc. | 2017-09-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |