NDC 0904-6735
memantine hydrochloride 28 mg capsule, extended release
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-249.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Pithampur, India | Makes it and packages it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
| Lupin Limited | Nagpur, India | Makes it and packages it | Problems found, fixed voluntarilyJul 11, 2023 · 4 inspections |
Recalls
- Apr 24, 2020 · Class III · The Harvard Drug Group
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Lots: Lot #: M02199D, M02246D, Exp 5/2020 - Feb 12, 2020 · Class II · Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Lots: Lot #: H900330, exp. date 11/2020. - Dec 13, 2019 · Class III · The Harvard Drug Group
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Lots: Lot# M02465D - Dec 10, 2019 · Class III · Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Lots: Lot #: H901787, H901788, Exp March 2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Memantine: every company that makes it
- Form
- capsule, extended release
- Strength
- 28 mg
- Approval
- ANDA ANDA206028
- On the market since
- Feb 20, 2018
- Package NDCs
0904-6735-61- Official label
- DailyMed (National Library of Medicine), updated Oct 16, 2026
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