Quick answers
- What is Amantadine used for?
- The FDA-approved label (Amantadine, American Health Packaging, June 23, 2026) says: “Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amantadine have a boxed warning?
- No. None of the 54 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Amantadine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amantadine been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started February 13, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Amantadine?
- 35 companies list prescription products of Amantadine in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and Chartwell RX, LLC.
What Amantadine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. …
— FDA label: Amantadine, American Health Packaging, effective June 23, 2026. Read the full label on DailyMed →
The FDA has 54 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 54 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Solution · Tablet · Capsule, liquid filled · Capsule, coated pellets · Capsule, gelatin coated |
|---|---|
| Route | Oral |
| Prescription products | 61 in the FDA NDC Directory |
| Brand names | Gocovri |
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 |
|---|---|---|
| amantadine hydrochloride 100 mg capsule | Generic | $0.1410 per capsule |
| amantadine hydrochloride 100 mg capsule, gelatin coated | Generic | $0.1410 per capsule |
| amantadine hydrochloride 100 mg capsule, liquid filled | Generic | $0.1410 per capsule |
| amantadine hydrochloride 100 mg tablet | Generic | $0.3096 per tablet |
| amantadine hydrochloride 50 mg/5 mL solution | Generic | $0.0499 per mL |
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 Prepack7 products
- Proficient Rx LP4 products
- Chartwell RX, LLC3 products
- Coupler LLC3 products
- Direct_Rx3 products
- AvKARE2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Alembic Pharmaceuticals Inc.2 products
- Upsher-Smith Laboratories, LLC2 products
- Marlex Pharmaceuticals, Inc.2 products
- AvPAK2 products
- Strides Pharma Inc.2 products
- American Health Packaging2 products
- Alembic Pharmaceuticals Limited2 products
- Adamas Pharma, LLC2 products
- Supernus Pharmaceuticals, Inc.2 products
- Major Pharmaceuticals1 product
- Bajaj Medical, LLC1 product
- Cardinal Health 107, LLC1 product
- Rising Pharma Holdings, Inc.1 product
- Patrin Pharma, Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Xttrium Laboratories, Inc.1 product
- St. Mary's Medical Park Pharmacy1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Strides Pharma Science Limited1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- Bionpharma Inc.1 product
- Advagen Pharma Limited1 product
- Atlantic Biologicals Corp.1 product
- Epic Pharma, LLC1 product
- A-S Medication Solutions1 product
- Zydus Lifesciences Limited1 product
- Zhejiang Jutai Pharmaceutical Co., Ltd.1 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 |
|---|---|---|---|
| NDA208944 GOCOVRI | Supernus Pharms | August 24, 2017 | 3, latest July 10, 2025 2025: Labeling · 2021: Efficacy · 2020: Labeling |
Generic approvals (21)
- ANDA070589Upsher Smith Labs · January 7, 1987
- ANDA071293Sandoz · February 18, 1987
- ANDA074028Chartwell Rx · June 28, 1993
- ANDA074509Pharm Assoc · July 17, 1995
- ANDA075060Pharmobedient · December 24, 1998
- ANDA075819Pharmobedient · September 11, 2002
- ANDA076186Upsher Smith Labs · December 16, 2002
- ANDA078720Bionpharma · May 29, 2008
- ANDA208278Zydus Pharms · May 31, 2016
- ANDA209047Strides Pharma · June 7, 2017
- ANDA209035Strides Pharma · June 9, 2017
- ANDA209171Heritage Pharma · June 12, 2017
- ANDA208966Alembic · June 21, 2017
- ANDA210129Rising · March 2, 2020
- ANDA210215Pharmobedient · March 10, 2020
- ANDA212044Rubicon Research · May 21, 2020
- ANDA214284Alembic · October 15, 2020
- ANDA214178Pharmobedient · August 20, 2021
- ANDA211354Onesource · February 18, 2022
- ANDA214580Humanwell Puracap · December 20, 2022
- ANDA218598Zhejiang Jutai Pharm · September 26, 2024
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.
-
February 13, 2026 · Class II · Ongoing · D-0341-2026
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. — AvKARE
-
March 15, 2021 · Class II · Terminated · D-0592-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00 — Cardinal Health Inc.
-
March 30, 2018 · Class II · Terminated · D-0633-2018
Failed Dissolution Specifications
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15 — AVKARE 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
| RxCUI (RxNorm) | 849385, 849389, 849395 |
|---|---|
| SPL set ID of the quoted label | 5119801d-a5cb-4adf-96b2-08cc3a0ba594 |
| FDA labels (SPL) | 54 |
| FDA applications | NDA208944, 21 ANDA |
| Active ingredients (FDA) | AMANTADINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amantadine, American Health Packaging, effective June 23, 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 →