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amantadine hydrochloride 100 mg Capsule, 30-count — NDC 68382-0512-06 package photo
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amantadine hydrochloride 100 mg Capsule, 30-count — NDC 68382-512-06 (Billing 68382-0512-06)

by Zydus Pharmaceuticals (USA) Inc. · 30 CAPSULE in 1 BOTTLE

This is a package of 30 capsules of amantadine hydrochloride 100 mg Capsule from Zydus Pharmaceuticals (USA) Inc., marketed since Aug 2016 and currently FDA-listed.

NDC 68382-0512-06
🏷️ FDA NDC (as labeled) 68382-512-06 billing pads the product segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.2518/unit — full pricing hub ↓
Product page 68382-0512-01 Also comes in: 100 capsules 68382-512-01 100 capsules 68382-512-77 500 capsules 68382-512-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Amantadine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 13, 2026 — Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. (AvKARE) · FDA recall D-0341-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68382-512-06
Product NDC 68382-512
11-digit billing NDC 68382051206
RxCUI 849389
UNII M6Q1EO9TD0
Application # ANDA208278
SPL Set ID 609dc911-1e9d-4ebd-b64b-f44054e5582e
Established class (EPC) Influenza A M2 Protein Inhibitor
Mechanism of action M2 Protein Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-08-04
Route ORAL
Dosage form CAPSULE
Substance AMANTADINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 73200010100105
GPI class Amantadine HCl
GCN Seq No 004575
GCN 17520
HICL code 001898
Ingredient (HICL) Amantadine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6A
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Other
AHFS code 08:18.04.00
AHFS class Adamantane Antivirals
FDB label name AMANTADINE 100 MG CAPSULE
FDB brand name Amantadine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004575
  • GCN: 17520
  • GPI-14 (Medi-Span): 73200010100105
  • HICL (First Databank): 001898
  • AHFS class code: 08:18.04.00
  • RxCUI (RxNorm): 849389
Why two NDCs? The FDA registers this code as 68382-512-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68382-0512-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Influenza A M2 Protein Inhibitor class.

Pharmacologic class Influenza A M2 Protein Inhibitor
Drug family (ATC) Adamantane derivatives
How it works M2 Protein Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name AMANTADINE 100 MG CAPSULE Ingredient Amantadine Hcl
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Standard amantadine capsules, tablets and oral solution prevent and treat influenza A and treat parkinsonism and drug-induced movement problems. Gocovri...
  • Take it by mouth exactly as your prescriber directs. Standard forms can be taken once a day or split into two doses. Gocovri is taken at bedtime and swallowed whole, with or withou...
  • Common ones include dizziness, dry mouth, constipation, leg swelling, and sometimes hallucinations. Stand up slowly to avoid lightheadedness. Call me or your doctor if you see thin...
  • Call for thoughts of suicide, new depression, hallucinations, fainting, falling asleep during daily activities, or sudden blurry vision or eye pain. Also call about uncontrollable...
📖 Read our full Amantadine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2518 $7.55 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68382-0512-01 68382-512-01 Main listing 100 CAPSULE in 1 BOTTLE $0.1425 / ea $14.25 2016-08-04 — Active
68382-0512-05 68382-512-05 500 CAPSULE in 1 BOTTLE $0.1425 / ea $71.26 2016-08-04 — Active
68382-0512-06 You're viewing this 30 CAPSULE in 1 BOTTLE — — 2016-08-04 — Active
68382-0512-77 68382-512-77 10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK — — 2016-08-04 — Active

This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 capsule in 1 bottle.
How does this package differ from NDC 68382-0512-01?
Both are amantadine hydrochloride 100 mg Capsule — the drug itself is identical. This page's package is the 30-count one, while NDC 68382-0512-01 is the 100 capsules package.
What NDC number is used to bill for this package of amantadine hydrochloride 100 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amantadine Hydrochloride 100 mg 00832-1015-00 Upsher-Smith 100 capsules $0.143 AB Availability likely —
Amantadine Hydrochloride 100 mg 00904-7042-06 Major 50 capsules $0.143 AB Availability likely —
Amantadine Hydrochloride 100 mg 16571-0834-01 Rising 100 capsules $0.143 AB Availability likely —
Amantadine Hydrochloride 100 mg 23155-0362-01 Heritage 100 capsules $0.143 AB Availability likely —
Amantadine HCl 100 mg 50268-0069-15 AvPAK 1 capsule $0.143 AB Availability likely —
Amantadine 100 mg 60687-0422-01 American 100 capsules $0.143 AB Availability likely —
Amantadine Hydrochloride 100 mg 62135-0609-90 Chartwell 90 capsules $0.143 AB Availability likely —
Amantadine HCl 100 mg 69452-0142-20 Bionpharma 100 capsules $0.143 AB Availability likely —
Amantadine Hydrochloride 100 mg 42543-0493-01 Strides 100 capsules $0.162 AB Availability likely —
Amantadine Hydrochloride 100 mg 00615-8263-39 NCS 30 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 10135-0693-01 Marlex 100 capsules — AB FDA listed —
Amantadine HCl 100 mg 42291-0125-50 AvKARE 500 capsules — AB FDA listed —
amantadine hydrochloride 100 mg 42806-0716-05 EPIC 500 capsules — AB FDA listed —
amantadine 100 mg 46708-0246-30 Alembic 30 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 50090-0020-00 A-S 16 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 60760-0779-30 ST. 30 capsules — AB FDA listed —
amantadine 100 mg 62332-0246-30 Alembic 30 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 64380-0862-06 Strides 100 capsules — AB FDA listed —
amantadine hydrochloride 100 mg 65841-0835-01 Zydus 100 capsules — AB FDA listed —
amantadine hydrochloride 100 mg 67046-1508-03 Coupler 30 capsules — AB FDA listed —
amantadine hydrochloride 100 mgthis 68382-0512-06 Zydus 30 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 71205-0223-20 Proficient 20 capsules — AB FDA listed —
amantadine hydrochloride 100 mg 71205-0702-20 Proficient 20 capsules — AB FDA listed —
amantadine hydrochloride 100 mg 71335-0469-01 Bryant 20 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 71335-2570-01 Bryant 20 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 71335-2664-01 Bryant 20 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 71335-2919-01 Bryant 500 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 71335-2959-01 Bryant 100 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 71335-9618-01 Bryant 20 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 72162-2408-01 Bryant 100 capsules — AB FDA listed —
Amantadine HCL 100 mg 72189-0412-30 Direct_Rx 30 capsules — AB FDA listed —
Amantadine HCL 100 mg 72189-0657-30 Direct 30 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 72888-0033-00 Advagen 1000 capsules — AB FDA listed —
amantadine hydrochloride 100 mg 73190-0094-50 AvKARE 500 capsules — AB FDA listed —
Amantadine Hydrochloride 100 mg 82804-0196-20 Proficient 20 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Aug 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerZydus Pharmaceuticals (USA) Inc.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA208278 (ANDA)
Labeler code68382
First marketedAug 2016
Product typeHuman Prescription Drug
Portfolio173 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection.

Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment Amantadine hydrochloride capsules, USP are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness.

There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules, USP will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules, USP are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules, USP.

Amantadine hydrochloride capsules, USP are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness.

Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules, USP. Parkinson’s Disease/Syndrome Amantadine hydrochloride capsules, USP are indicated in the treatment of idiopathic Parkinson's disease (Paralysis Agitans), postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication.

It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinson's disease, amantadine is less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established. Drug-Induced Extrapyramidal Reactions Amantadine hydrochloride is indicated in the treatment of drug-induced extrapyramidal reactions.

Although anticholinergic-type side effects have been noted with amantadine when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function ( see Dosage for Impaired Renal Function ). Dosage for Prophylaxis and Treatment of Uncomplicated Influenza A Virus Illness Adult The adult daily dosage of amantadine hydrochloride capsules is 200 mg; two 100 mg capsules as a single daily dose. The daily dosage may be split into one capsule of 100 mg twice a day.

If central nervous system effects develop in once-a-day dosage, a split dosage schedule may reduce such complaints. In persons 65 years of age or older, the daily dosage of amantadine hydrochloride capsules is 100 mg. A 100 mg daily dose has also been shown in experimental challenge studies to be effective as prophylaxis in healthy adults who are not at high risk for influenza-related complications.

However, it has not been demonstrated that a 100 mg daily dose is as effective as a 200 mg daily dose for prophylaxis, nor has the 100 mg daily dose been studied in the treatment of acute influenza illness. In recent clinical trials, the incidence of central nervous system (CNS) side effects associated with the 100 mg daily dose was at or near the level of placebo. The 100 mg dose is recommended for persons who have demonstrated intolerance to 200 mg of amantadine hydrochloride daily because of CNS or other toxicities.

Pediatric Patients 1 yr. to 9 yrs. of age The total daily dose should be calculated on the basis of 2 to 4 mg/lb/day (4.4 to 8.8 mg/kg/day), but not to exceed 150 mg per day. 9 yrs. to 12 yrs. of age The total daily dose is 200 mg given as one capsule of 100 mg twice a day. The 100 mg daily dose has not been studied in this pediatric population.

Therefore, there are no data which demonstrate that this dose is as effective as or is safer than the 200 mg daily dose in this patient population. Prophylactic dosing should be started in anticipation of an influenza A outbreak and before or after contact with individuals with influenza A virus respiratory tract illness. Amantadine hydrochloride capsules should be continued daily for at least 10 days following a known exposure.

If amantadine is used chemoprophylactically in conjunction with inactivated influenza A virus vaccine until protective antibody responses develop, then it should be administered for 2 to 4 weeks after the vaccine has been given. When inactivated influenza A virus vaccine is unavailable or contraindicated, amantadine hydrochloride capsules should be administered for the duration of known influenza A in the community because of repeated and unknown exposure. Treatment of influenza A virus illness should be started as soon as possible, preferably within 24 to 48 hours after onset of signs and symptoms, and should be continued for 24 to 48 hours after the disappearance of signs and symptoms.

Dosage for Parkinsonism Adult The usual dose of amantadine hydrochloride capsules is 100 mg twice a day when used alone. Amantadine has an onset of action usually within 48 hours. The initial dose of amantadine hydrochloride capsules is 100 mg daily for patients with serious associated medical illnesses or who are receiving high doses of other antiparkinson drugs.

After one to several weeks at 100 mg once daily, the dose may be increased to 100 mg twice daily, if necessary. Occasionally, patients whose responses are not optimal with amantadine hydrochloride capsules at 200 mg daily may benefit from an increase up to 400 mg daily in divided doses. However, such patients should be supervised closely by their physicians.

Patients initially deriving benefit from amantadine hydrochloride capsules not uncommonly experience a fall-off of effectiveness after a few months. Benefit may be regained by increasing the dose to 300 mg daily. Alternatively, temporary discontinuation of amantadine hydrochloride capsules for several weeks, followed by reinitiation of the drug,…

⛔ Contraindications 27 words ▾

CONTRAINDICATIONS Amantadine hydrochloride capsules, USP are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride capsules, USP.

⚠️ Warnings ~2 min read ▾

WARNINGS Deaths Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1gram. Acute toxicity may be attributable to the anticholinergic effects of amantadine.

Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension ( see OVERDOSAGE ). Deaths due to drug accumulation (overdosage) have been reported in patients with renal impairment, who were prescribed higher than recommended doses of Amantadine Hydrochloride for their level of renal function (see DOSAGE AND ADMINISTRATION; Dosage of Impaired Renal Function and OVERDOSAGE ).

Suicide Attempts Suicide attempts, some of which have been fatal, have been reported in patients treated with amantadine, many of whom received short courses for influenza treatment or prophylaxis. The incidence of suicide attempts is not known and the pathophysiologic mechanism is not understood. Suicide attempts and suicidal ideation have been reported in patients with and without prior history of psychiatric illness.

Amantadine can exacerbate mental problems in patients with a history of psychiatric disorders or substance abuse. Patients who attempt suicide may exhibit abnormal mental states which include disorientation, confusion, depression, personality changes, agitation, aggressive behavior, hallucinations, paranoia, other psychotic reactions and somnolence or insomnia. Because of the possibility of serious adverse effects, caution should be observed when prescribing amantadine hydrochloride capsules to patients being treated with drugs having CNS effects, or for whom the potential risks outweigh the benefit of treatment.

CNS Effects Patients with a history of epilepsy or other "seizures" should be observed closely for possible increased seizure activity. Patients receiving amantadine hydrochloride capsules who note central nervous system effects or blurring of vision should be cautioned against driving or working in situations where alertness and adequate motor coordination are important. Other Patients with a history of congestive heart failure or peripheral edema should be followed closely as there are patients who developed congestive heart failure while receiving amantadine hydrochloride capsules.

Patients with Parkinson's disease improving on amantadine hydrochloride capsules should resume normal activities gradually and cautiously, consistent with other medical considerations, such as the presence of osteoporosis or phlebothrombosis. Because amantadine hydrochloride capsules has anticholinergic effects and may cause mydriasis, it should not be given to patients with untreated angle closure glaucoma. Corneal Edema Corneal edema has been reported in patients taking amantadine.

Symptoms include sudden onset of blurry vision, or progressive vision loss, with or without eye pain. Corneal involvement is usually bilateral. Onset can occur from a few weeks to several years after starting amantadine.

Resolution of symptoms typically begins within weeks of amantadine cessation. However, corneal grafts have been required in some patients when the condition is not recognized. Permanent damage can occur if amantadine is continued.

Ask patients if their vision has changed and obtain ophthalmologic examination to rule out corneal edema should vision changes occur after initiation of therapy with amantadine hydrochloride. If corneal edema occurs, taper and discontinue amantadine hydrochloride [see Dosage and Administration ] .

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS The adverse reactions reported most frequently at the recommended dose of amantadine (5 to 10%) are: nausea, dizziness (lightheadedness), and insomnia. Less frequently (1 to 5%) reported adverse reactions are: depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue. Infrequently (0.1 to 1%) occurring adverse reactions are: congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, and visual disturbance, including punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve palsy.

Rare (less than 0.1%) occurring adverse reactions are: instances of convulsion, leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes, suicidal attempt, suicide, and suicidal ideation ( see WARNINGS ). Other adverse reactions reported during postmarketing experience with amantadine usage include: Nervous System/Psychiatric coma, stupor, delirium, hypokinesia, hypertonia, delusions, aggressive behavior, paranoid reaction, manic reaction, involuntary muscle contractions, gait abnormalities, paresthesia, EEG changes, and tremor.

Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech; Cardiovascular cardiac arrest, arrhythmias including malignant arrhythmias, hypotension, and tachycardia; Respiratory acute respiratory failure, pulmonary edema, and tachypnea; Gastrointestinal dysphagia; Hematologic leukocytosis, agranulocytosis; Special Senses Keratitis, mydriasis, and corneal edema; Skin and Appendages pruritus and diaphoresis; Miscellaneous neuroleptic malignant syndrome ( see WARNINGS ), allergic reactions including anaphylactic reactions, edema, and fever.

Laboratory Test elevated: CPK, BUN, serum creatinine, alkaline phosphatase, LDH, bilirubin, GGT, SGOT, and SGPT.

🔄 Drug Interactions 208 words ▾

Drug Interactions Careful observation is required when amantadine is administered concurrently with central nervous system stimulants. Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine. Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson's disease, however, it is not known if other phenothiazines produce a similar response.

Coadministration of triamterene and hydrochlorothiazide capsules resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine (hydrochloride capsules) 100 mg t.i.d. for Parkinson's disease 1 . It is not known which of the components of triamterene and hydrochlorothiazide capsules contributed to the observation or if related drugs produce a similar response. Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%.

The concurrent use of amantadine with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of amantadine, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus.

Trivalent inactivated influenza vaccine can be administered at any time relative to use of amantadine.

🤰 Pregnancy ~1 min read ▾

Pregnancy Pregnancy Category C The effect of amantadine on embryofetal and peri-postnatal development has not been adequately tested, that is, in studies conducted under Good Laboratory Practice (GLP) and according to current recommended methodology. However, in two non-GLP studies in rats in which females were dosed from 5 days prior to mating to Day 6 of gestation or on Days 7 to 14 of gestation, amantadine produced increases in embryonic death at an oral dose of 100 mg/kg (or 3 times the maximum recommended human dose on a mg/m 2 basis).

In the non-GLP rat study in which females were dosed on Days 7 to 14 of gestation, there was a marked increase in severe visceral and skeletal malformations at oral doses of 50 and 100 mg/kg (or 1.5 and 3 times, respectively, the maximum recommended human dose on a mg/m 2 basis). The no-effect dose for teratogenicity was 37 mg/kg (equal to the maximum recommended human dose on a mg/m 2 basis). The safety margins reported may not accurately reflect the risk considering the questionable quality of the study on which they are based.

There are no adequate and well-controlled studies in pregnant women. Human data regarding teratogenicity after maternal use of amantadine is scarce. Tetralogy of Fallot and tibial hemimelia (normal karyotype) occurred in an infant exposed to amantadine during the first trimester of pregnancy (100 mg P.O. for 7 days during the 6th and 7th week of gestation).

Cardiovascular maldevelopment (single ventricle with pulmonary atresia) was associated with maternal exposure to amantadine (100 mg/d) administered during the first 2 weeks of pregnancy. Amantadine should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.

🧒 Pediatric Use 23 words ▾

Pediatric Use The safety and efficacy of amantadine in newborn infants and infants below the age of 1 year have not been established.

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Because some patients have attempted suicide by overdosing with amantadine, prescriptions should be written for the smallest quantity consistent with good patient management.

Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension.

Pulmonary edema and respiratory distress (including adult respiratory distress syndrome – ARDS) have been reported; renal dysfunction including increased BUN, decreased creatinine clearance and renal insufficiency can occur. Central nervous system effects that have been reported include insomnia, anxiety, agitation, aggressive behavior, hypertonia, hyperkinesia, ataxia, gait abnormality, tremor, confusion, disorientation, depersonalization, fear, delirium, hallucinations, psychotic reactions, lethargy, somnolence and coma.

Seizures may be exacerbated in patients with prior history of seizure disorders. Hyperthermia has also been observed in cases where a drug overdose has occurred. There is no specific antidote for an overdose of amantadine.

However, slowly administered intravenous physostigmine in 1 and 2 mg doses in an adult 2 at 1- to 2-hour intervals and 0.5 mg doses in a child 3 at 5- to 10-minute intervals up to a maximum of 2 mg/hour have been reported to be effective in the control of central nervous system toxicity caused by amantadine hydrochloride. For acute overdosing, general supportive measures should be employed along with immediate gastric lavage or induction of emesis. Fluids should be forced, and if necessary, given intravenously.

The pH of the urine has been reported to influence the excretion rate of amantadine. Since the excretion rate of amantadine increases rapidly when the urine is acidic, the administration of urine acidifying drugs may increase the elimination of the drug from the body. The blood pressure, pulse, respiration and temperature should be monitored.

The patient should be observed for hyperactivity and convulsions; if required, sedation, and anticonvulsant therapy should be administered. The patient should be observed for the possible development of arrhythmias and hypotension; if required, appropriate antiarrhythmic and antihypotensive therapy should be given. Electrocardiographic monitoring may be required after ingestion, since malignant tachyarrhythmias can appear after overdose.

Care should be exercised when administering adrenergic agents, such as isoproterenol, to patients with an amantadine overdose, since the dopaminergic activity of amantadine has been reported to induce malignant arrhythmias. The blood electrolytes, urine pH and urinary output should be monitored. If there is no record of recent voiding, catheterization should be done.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics Mechanism of Action Antiviral The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the transmembrane domain of the viral M2 protein. In certain cases, amantadine is also known to prevent virus assembly during virus replication.

It does not appear to interfere with the immunogenicity of inactivated influenza A virus vaccine. Antiviral Activity Amantadine inhibits the replication of influenza A virus isolates from each of the subtypes, i.e., H1N1, H2N2 and H3N2. It has very little or no activity against influenza B virus isolates.

A quantitative relationship between the in vitro susceptibility of influenza A virus to amantadine and the clinical response to therapy has not been established in man. Sensitivity test results, expressed as the concentration of amantadine required to inhibit by 50% the growth of virus (ED 50 ) in tissue culture vary greatly (from 0.1 mcg/mL to 25 mcg/mL) depending upon the assay protocol used, size of virus inoculum, isolates of influenza A virus strains tested, and the cell type used. Host cells in tissue culture readily tolerated amantadine up to a concentration of 100 mcg/mL.

Drug Resistance Influenza A variants with reduced in vitro sensitivity to amantadine have been isolated from epidemic strains in areas where adamantane derivatives are being used. Influenza viruses with reduced in vitro sensitivity have been shown to be transmissible and to cause typical influenza illness. The quantitative relationship between the in vitro sensitivity of influenza A variants to amantadine and the clinical response to therapy has not been established.

Mechanism of Action Parkinson's Disease The mechanism of action of amantadine in the treatment of Parkinson's disease and drug-induced extrapyramidal reactions is not known. Data from earlier animal studies suggest that amantadine may have direct and indirect effects on dopamine neurons. More recent studies have demonstrated that amantadine is a weak, non-competitive NMDA receptor antagonist (K 1 = 10μM).

Although amantadine has not been shown to possess direct anticholinergic activity in animal studies, clinically, it exhibits anticholinergic-like side effects such as dry mouth, urinary retention, and constipation. Pharmacokinetics Amantadine is well absorbed orally. Maximum plasma concentrations are directly related to dose for doses up to 200 mg/day.

Doses above 200 mg/day may result in a greater than proportional increase in maximum plasma concentrations. It is primarily excreted unchanged in the urine by glomerular filtration and tubular secretion. Eight metabolites of amantadine have been identified in human urine.

One metabolite, an N-acetylated compound, was quantified in human urine and accounted for 5 to 15% of the administered dose. Plasma acetylamantadine accounted for up to 80% of the concurrent amantadine plasma concentration in 5 of 12 healthy volunteers following the ingestion of a 200 mg dose of amantadine. Acetylamantadine was not detected in the plasma of the remaining seven volunteers.

The contribution of this metabolite to efficacy or toxicity is not known. There appears to be a relationship between plasma amantadine concentrations and toxicity. As concentration increases, toxicity seems to be more prevalent, however, absolute values of amantadine concentrations associated with adverse effects have not been fully defined.

Amantadine pharmacokinetics were determined in 24 normal adult male volunteers after the oral administration of a single amantadine hydrochloride 100 mg soft gel capsule. The mean ± SD maximum plasma concentration was 0.22 ± 0.03 mcg/mL (range: 0.18 to 0.32 mcg/mL). The time to peak concentration was 3.3 ± 1.5 hours (range 1.5 to 8 hours).

The apparent oral clearance was 0.28 ±

0.11L/hr/kg (range: 0.14 to

0.62L/hr/kg). Th…

📦 How Supplied / Storage and Handling 102 words ▾

HOW SUPPLIED Amantadine Hydrochloride Capsules, USP, 100 mg are white to off-white powder filled in size "2" empty hard gelatin capsule having red opaque colored cap imprinted with "652" in white ink and red opaque colored body and are supplied as follows: NDC 68382-512-06 in bottles of 30 capsules with child-resistant closure NDC 68382-512-01 in bottles of 100 capsules NDC 68382-512-05 in bottles of 500 capsules NDC 68382-512-77 in unit-dose blister cartons of 100 Capsules (10 X 10 Unit-dose) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

📋 Description 142 words ▾

DESCRIPTION Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.7 with a molecular formula C 10 H 17 N.HCl. It has the following structural formula: Amantadine hydrochloride, USP is a white or almost white, crystalline powder, freely soluble in water, ethanol and methanol; soluble in chloroform; sparingly soluble in methylene chloride; practically insoluble in ether.

Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each amantadine hydrochloride capsule, USP intended for oral administration contains 100 mg of amantadine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: crosscarmellose sodium, ethyl cellulose, FD&C blue #1, FD&C red #40, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and titanium dioxide.

Each capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide. Meets USP Dissolution Test 2 figure

💬 Information for Patients 145 words ▾

Information for Patients Patients should be advised of the following information: Blurry vision, eye pain, loss of vision, and/or impaired mental acuity may occur. Gradually increase physical activity as the symptoms of Parkinson's disease improve. Avoid excessive alcohol usage, since it may increase the potential for CNS effects such as dizziness, confusion, light-headedness and orthostatic hypotension.

Avoid getting up suddenly from a sitting or lying position. If dizziness or lightheadedness occurs, notify physician. Notify physician if mood/mental changes, swelling of extremities, difficulty urinating and/or shortness of breath occur.

Do not take more medication than prescribed because of the risk of overdose. If there is no improvement in a few days, or if medication appears less effective after a few weeks, discuss with a physician. Consult physician before discontinuing medication.

Seek medical attention immediately if it is suspected that an overdose of medication has been taken.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules68382-0512-01 22,713 Rx · $419,860
500 capsules68382-0512-05 5,966 Rx · $100,432
30 capsules this page68382-0512-06 No Medicaid data
100 capsules68382-0512-77 No Medicaid data
Drug total (last 4 qtrs): 28,679 Rx · 1,805,160 units · $520,292 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Pharmaceuticals (USA) Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 100 capsules (68382-0512-01), 100 capsules (68382-0512-77), 500 capsules (68382-0512-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Pharmaceuticals (USA) Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68382-0500-01 · Zydus 68382-0520-01 · Zydus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.