Quick answers
- What is Memantine hydrochloride used for?
- The FDA-approved label (Memantine Hydrochloride, Cardinal Health 107, LLC, June 5, 2026) says: “Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablets are an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Memantine hydrochloride have a boxed warning?
- No. None of the 67 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Memantine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Memantine hydrochloride been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started March 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Memantine hydrochloride?
- 39 companies list prescription products of Memantine hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Macleods Pharmaceuticals Limited.
What Memantine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablets are an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
— FDA label: Memantine Hydrochloride, Cardinal Health 107, LLC, effective June 5, 2026. Read the full label on DailyMed →
The FDA has 67 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 67 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Capsule, extended release · Tablet, film coated · Solution · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 120 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| memantine hydrochloride 10 mg tablet | Generic | $0.0630 per tablet |
| memantine hydrochloride 10 mg tablet, film coated | Generic | $0.0630 per tablet |
| memantine hydrochloride 14 mg capsule, extended release | Generic | $0.3435 per capsule |
| memantine hydrochloride 2 mg/mL solution | Generic | $0.3804–$0.8106 per mL 3 packages, lowest to highest |
| memantine hydrochloride 21 mg capsule, extended release | Generic | $0.3537 per capsule |
| memantine hydrochloride 28 mg capsule, extended release | Generic | $0.3252 per capsule |
| memantine hydrochloride 5 mg tablet | Generic | $0.0782 per tablet |
| memantine hydrochloride 5 mg tablet, film coated | Generic | $0.0782 per tablet |
| memantine hydrochloride 7 mg capsule, extended release | Generic | $0.3073 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack11 products
- A-S Medication Solutions7 products
- Macleods Pharmaceuticals Limited7 products
- Lupin Pharmaceuticals, Inc.6 products
- Zydus Lifesciences Limited6 products
- Aurobindo Pharma Limited6 products
- Amneal Pharmaceuticals LLC6 products
- Cardinal Health 107, LLC4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Vitruvias Therapeutics, Inc.4 products
- Slate Run Pharmaceuticals, LLC4 products
- Rising Pharma Holdings, Inc.4 products
- Aphena Pharma Solutions - Tennessee, LLC4 products
- Chartwell RX, LLC3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Major Pharmaceuticals3 products
- NorthStar RxLLC2 products
- American Health Packaging2 products
- Ajanta Pharma USA Inc.2 products
- Unichem Pharmaceuticals (USA), Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Dr. Reddys Laboratories Limited2 products
- Carlsbad Technology, Inc.2 products
- Actavis Pharma, Inc.2 products
- AvPAK2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Viona Pharmaceuticals Inc2 products
- Upsher-Smith Laboratories, LLC2 products
- Alembic Pharmaceuticals Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Coupler LLC1 product
- Seton Pharmaceuticals1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Remedyrepack Inc.1 product
- Direct_Rx1 product
- Apotex Corp.1 product
- Preferred Pharmaceuticals Inc.1 product
- DirectRx1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021487 NAMENDA | Abbvie | October 16, 2003 | 14, latest November 2, 2018 2018: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
Generic approvals (26)
- ANDA090048DR Reddys Labs Ltd · April 14, 2010
- ANDA090058Sun Pharm · May 5, 2010
- ANDA090041Amneal Pharms · April 10, 2015
- ANDA090051Lupin · April 10, 2015
- ANDA090043Upsher Smith Labs · July 31, 2015
- ANDA200022Unichem · October 13, 2015
- ANDA200891Alembic · October 13, 2015
- ANDA202790Macleods Pharms · October 13, 2015
- ANDA202840Macleods Pharms Ltd · October 13, 2015
- ANDA203175Aurobindo Pharma Ltd · October 13, 2015
- ANDA204033Chartwell Molecular · October 13, 2015
- ANDA206528Ajanta Pharma Ltd · November 30, 2015
- ANDA206028Lupin · September 28, 2016
- ANDA206032Rising · September 28, 2016
- ANDA205825Amneal Pharms · October 12, 2016
- ANDA090961Zydus Lifesciences · July 10, 2017
- ANDA203293Zydus Pharms · August 3, 2017
- ANDA209955Apotex · February 9, 2018
- ANDA090244Chartwell · July 11, 2018
- ANDA212947Pharmobedient · April 3, 2020
- ANDA210319Pharmazone · August 31, 2020
- ANDA211100Yichang Humanwell · April 2, 2021
- ANDA214651Aurobindo Pharma Ltd · August 9, 2021
- ANDA204389Hetero Labs Ltd V · September 26, 2022
- ANDA213985H2-Pharma · October 11, 2022
- ANDA206310Macleods Pharms · August 28, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 24, 2026 · Class II · Ongoing · D-0485-2026
Failed Dissolution Specifications
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61 — The Harvard Drug Group LLC
-
February 12, 2020 · Class II · Terminated · D-0855-2020
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)- — Lupin Pharmaceuticals Inc.
-
December 10, 2019 · Class III · Terminated · D-0629-2020
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, M — Lupin Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Memantine Hydrochloride, Cardinal Health 107, LLC, effective June 5, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →