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Benzonatate 200 mg Capsule, Liquid Filled, 100-count — NDC 68382-0091-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Benzonatate 200 mg Capsule, Liquid Filled, 100-count — NDC 68382-091-01 (Billing 68382-0091-01)

by Zydus Pharmaceuticals USA Inc. · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Benzonatate 200 mg Capsule, Liquid Filled from Zydus Pharmaceuticals USA Inc., marketed since Apr 2007 and currently FDA-listed; retail pharmacies pay about $0.1013 per capsule (NADAC). It is this product's only package size.

NDC 68382-0091-01
🏷️ FDA NDC (as labeled) 68382-091-01 billing pads the product segment with a zero
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 Benzonatate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 26, 2023 — Superpotent drug: Assay results were slightly above specification at the time zero point. (Amerisource Health Services LLC) · FDA recall D-0257-2024
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) 68382-091-01
Product NDC 68382-091
11-digit billing NDC 68382009101
NCPDP billing unit EA — each (per item)
RxCUI 197397, 283417
UNII 5P4DHS6ENR
Application # ANDA040597
SPL Set ID 331c70dc-005e-4d96-a35c-4d2d810aa3b1
Established class (EPC) Non-narcotic Antitussive
Physiologic effect Decreased Tracheobronchial Stretch Receptor Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-04-09
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance BENZONATATE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 43102010000110
GCN Seq No 044168
GCN 93007
HICL code 001929
Ingredient (HICL) Benzonatate
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 H6C
Therapeutic class — specific (HIC3) Antitussives, Non-Opioid
AHFS code 48:08.00.00
AHFS class Antitussives
FDB label name BENZONATATE 200 MG CAPSULE
FDB brand name Benzonatate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 044168
  • GCN: 93007
  • GPI-14 (Medi-Span): 43102010000110
  • HICL (First Databank): 001929
  • AHFS class code: 48:08.00.00
  • RxCUI (RxNorm): 197397
Why two NDCs? The FDA registers this code as 68382-091-01 — 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 → 68382-0091-01. 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 Non-narcotic Antitussive class.

Pharmacologic class Non-narcotic Antitussive
Drug family (ATC) Other cough suppressants
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 BENZONATATE 200 MG CAPSULE Ingredient Benzonatate
📖 What it is MedlinePlus · NLM

Benzonatate is used to relieve cough. Benzonatate is in a class of medications called antitussives (cough suppressants). It works by reducing the cough reflex in the lungs and air passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No, benzonatate is not related to codeine or narcotic cough medicines. Instead of working on your brain, it acts more like a local anesthetic inside your airways — it numbs the ner...
  • What exactly does benzonatate do — is it like cough syrup with codeine?
  • This is one of the most important things to know about benzonatate. The medicine inside acts like a numbing agent — if the capsule breaks open in your mouth, it can rapidly numb yo...
  • Why does my pharmacist keep telling me not to chew the capsule?
📖 Read our full Benzonatate guide →
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 eaPer package
Retail pharmacies payNADAC · weekly $0.101 $10.13 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.3815 $38.15 / 100 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.144 $0.101
▼ Down 27% over the last 24 months.
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 Marketing startMarketing endStatus
68382-0091-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2007-04-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benzonatate 200 mg 23155-0899-01 Heritage 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 31722-0958-01 Camber 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 42806-0715-01 Epic 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 49483-0947-01 TIME 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 62135-0441-31 Chartwell 300 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 64380-0713-06 Strides 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 64980-0635-01 Rising 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 67877-0575-01 Ascend 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mgthis 68382-0091-01 Zydus 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 69452-0144-20 Bionpharma 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 51224-0001-50 TAGI 100 capsules $0.120 AA FDA listed +19%
Benzonatate 200 mg 25000-0003-03 MARKSANS 30 capsules — AA FDA listed —
Benzonatate 200 mg 42291-0092-01 AvKARE 100 capsules — AA FDA listed —
Benzonatate 200 mg 42708-0082-21 QPharma, 21 capsules — AA FDA listed —
Benzonatate 200 mg 42708-0171-21 QPharma 21 capsules — AA FDA listed —
Benzonatate 200 mg 50090-6080-00 A-S 30 capsules — AA FDA listed —
Benzonatate 200 mg 50090-6294-00 A-S 30 capsules — AA FDA listed —
Benzonatate 200 mg 51655-0762-20 Northwind 20 capsules — AA FDA listed —
Benzonatate 200 mg 51655-0776-52 Northwind 30 capsules — AA FDA listed —
Benzonatate 200 mg 60429-0914-01 Golden 100 capsules — AA FDA listed —
Benzonatate 200 mg 63187-0606-14 Proficient 14 capsules — AA FDA listed —
Benzonatate 200 mg 63629-1229-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 63629-2475-01 Bryant 500 capsules — AA FDA listed —
Benzonatate 200 mg 63629-2476-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 65162-0537-10 Amneal 100 capsules — AA FDA listed —
Benzonatate 200 mg 65841-0843-01 Zydus 100 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1464-03 RedPharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1751-03 RedPharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1833-03 Redpharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2153-01 Redpharm 15 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2202-03 Redpharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2244-05 Redpharm 15 capsules — AA Discontinued —
Benzonatate 200 mg 68071-1395-03 NuCare 30 capsules — AA FDA listed —
Benzonatate 200 mg 68071-2562-03 NuCare 30 capsules — AA FDA listed —
Benzonatate 200 mg 68094-0901-50 Precision 100 capsules — AA FDA listed —
Benzonatate 200 mg 68788-8329-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mg 68788-8336-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mg 68788-8405-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mg 70518-2491-00 REMEDYREPACK 30 capsules — AA Discontinued —
Benzonatate 200 mg 70518-4182-00 REMEDYREPACK 30 capsules — AA FDA listed —
Benzonatate 200 mg 70518-4497-00 REMEDYREPACK 20 capsules — AA FDA listed —
benzonatate 200 mg 71205-0037-10 Proficient 10 capsules — — FDA listed —
Benzonatate 200 mg 71205-0605-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0643-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0673-06 Proficient 6 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0887-00 Proficient 100 capsules — AA FDA listed —
benzonatate 200 mg 71205-0972-00 Proficient 100 capsules — — FDA listed —
Benzonatate 200 mg 71335-0031-01 Bryant 30 capsules — AA FDA listed —
benzonatate 200 mg 71335-0725-01 Bryant 30 capsules — — FDA listed —
Benzonatate 200 mg 71335-1553-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-1880-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2021-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2486-00 Bryant 6 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2590-00 Bryant 6 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2788-01 Bryant 21 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2790-01 Bryant 21 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2853-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 72162-1316-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 72162-1560-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 72189-0192-20 DIRECT 20 capsules — AA FDA listed —
Benzonatate 200 mg 72189-0606-20 Direct_rx 20 capsules — AA FDA listed —
Benzonatate 200 mg 72789-0232-21 PD-Rx 21 capsules — AA FDA listed —
Benzonatate 200 mg 72865-0119-01 XLCare 100 capsules — AA FDA listed —
Benzonatate 200 mg 76420-0804-01 Asclemed 100 capsules — AA FDA listed —
Benzonatate 200 mg 85766-0068-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 200 mg 85766-0090-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 200 mg 71335-3169-01 Bryant 21 capsules — AA 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

🏛️
2007
On the market since
Apr 2007
📍
2026
Currently FDA-listed
19 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.

What it looks like

Color Yellow
ShapeOval
ImprintB
Size6 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 applicationANDA040597 (ANDA)
Labeler code68382
First marketedApr 2007
Product typeHuman Prescription Drug
Portfolio454 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 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

INDICATIONS AND USAGE Benzonatate capsules are indicated for the symptomatic relief of cough.

⏱️ Dosage and Administration 64 words ▾

DOSAGE AND ADMINISTRATION Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

⛔ Contraindications 7 words ▾

CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.

⚠️ Warnings 134 words ▾

WARNINGS Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules in combination with other prescribed drugs.

Accidental Ingestion and Death in Children Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion.

If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).

🤒 Adverse Reactions 73 words ▾

ADVERSE REACTIONS Potential Adverse Reactions to Benzonatate Capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS Sedation; headache; dizziness; mental confusion; visual hallucinations. GI Constipation; nausea; GI upset.

Dermatologic Pruritus; skin eruptions. Other Nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.

🧒 Pediatric Use 35 words ▾

Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

🆘 Overdosage 210 words ▾

OVERDOSAGE Intentional and unintentional overdose may result in death, particularly in children. The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms The signs and symptoms of overdose of benzonatate have been reported within 15 to 20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression.

Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion. Treatment In case of overdose, seek seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry.

Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.

Do not use CNS stimulants.

🧬 Clinical Pharmacology 63 words ▾

CLINICAL PHARMACOLOGY Benzonatate capsules act peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate capsules have no inhibitory effect on the respiratory center in recommended dosage.

📦 How Supplied / Storage and Handling 94 words ▾

HOW SUPPLIED Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "Z" containing pale yellow-colored clear viscous liquid and are supplied as follows: NDC 68382-247-01 in bottle of 100 capsules NDC 68382-247-05 in bottle of 500 capsules Benzonatate capsules USP, 200 mg are light yellow-colored, oval-shaped soft gelatin capsules, imprinted with "β" containing pale yellow-colored clear viscous liquid and are supplied as follows: NDC 68382-091-01 in bottle of 100 capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

📋 Description 58 words ▾

DESCRIPTION Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2,5,8,11,14,17,20,23,26-nonaoxaoctacosan-28-yl p -(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule for oral administration contains 100 mg or 200 mg of benzonatate. In addition, each capsule also contains the following inactive ingredients: gelatin, glycerin, noncrystallising sorbitol solution, methylparaben, propylparaben and purified water.

Structure forluma for Benzonatate

💬 Information for Patients 191 words ▾

Information for patients Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush benzonatate capsules.Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved.

If the symptoms worsen or persist, seek medical attention. Keep benzonatate capsules out of reach of children. Accidental ingestion resulting in death has been reported in children.

Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.

Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsules, skip that dose and take the next dose at the next scheduled time.

Do not take 2 doses of benzonatate capsules at one time.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication. Information for patients Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush benzonatate capsules.Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur.

If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention. Keep benzonatate capsules out of reach of children.

Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest.

If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg.

If you miss a dose of benzonatate capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate capsules at one time. Usage in Pregnancy Pregnancy Category C.

Animal reproduction studies have not been conducted with benzonatate capsules. It is also not known whether benzonatate capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate capsules should be given to a pregnant woman only if clearly needed.

Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when benzonatate capsules are administered to a nursing woman. Carcinogenesis, mutagenesis, impairment of fertility Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate capsules.

Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

🍼 Nursing Mothers 35 words ▾

Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when benzonatate capsules are administered to a nursing woman.

📄 Package Label / Principal Display Panel 50 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-247-01 in bottle of 100 capsules Benzonatate Capsules USP, 100 mg R x only 100 capsules ZYDUS NDC 68382-091-01 in bottle of 100 capsules Benzonatate Capsules USP, 200 mg R x only 100 capsules ZYDUS Structured formula for Benzonatate Capsules Structured formula for Benzonatate Capsules

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
54.5K
Units reimbursed last 4 qtrs
1.8M
Gross reimbursed last 4 qtrs
$671.4K
Avg / prescription
$12.32
Avg / unit
$0.3815
Latest quarter Q4 2025
10.1KRx
Medicaid pays / ea
$0.3815
gross reimbursed
vs
NADAC / ea
$0.1013
acquisition cost
=
Spread
+$0.2802
+277% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
59% FFS 41% MCO
Fee-for-service · 32,031 Rx Managed care · 22,468 Rx
State Medicaid map
Alaska: no data reported AK Maine: 745 units · 53.4 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: 4,582 units · 405 per 100k residents MT North Dakota: 1,950 units · 249 per 100k residents ND Minnesota: 23,178 units · 404 per 100k residents MN Wisconsin: 72,061 units · 1,219 per 100k residents WI Michigan: 33,592 units · 335 per 100k residents MI New York: 274,788 units · 1,404 per 100k residents NY Vermont: 1,544 units · 239 per 100k residents VT New Hampshire: no data reported NH Oregon: 29,310 units · 692 per 100k residents OR Nevada: 10,060 units · 315 per 100k residents NV Wyoming: 991 units · 170 per 100k residents WY South Dakota: 15,993 units · 1,740 per 100k residents SD Iowa: no data reported IA Illinois: 17,075 units · 136 per 100k residents IL Indiana: 32,687 units · 476 per 100k residents IN Ohio: 121,354 units · 1,030 per 100k residents OH Pennsylvania: 74,899 units · 578 per 100k residents PA New Jersey: 57,105 units · 615 per 100k residents NJ Massachusetts: no data reported MA California: 531,694 units · 1,365 per 100k residents CA Utah: 22,676 units · 664 per 100k residents UT Colorado: 5,681 units · 96.6 per 100k residents CO Nebraska: 11,089 units · 561 per 100k residents NE Missouri: 22,415 units · 362 per 100k residents MO Kentucky: 30,980 units · 684 per 100k residents KY West Virginia: 32,185 units · 1,818 per 100k residents WV Virginia: 29,350 units · 337 per 100k residents VA Maryland: 28,105 units · 455 per 100k residents MD Connecticut: 30,647 units · 847 per 100k residents CT Rhode Island: 2,150 units · 196 per 100k residents RI Arizona: 25,149 units · 338 per 100k residents AZ New Mexico: 14,328 units · 678 per 100k residents NM Kansas: 5,848 units · 199 per 100k residents KS Arkansas: no data reported AR Tennessee: 49,831 units · 699 per 100k residents TN North Carolina: 5,562 units · 51.3 per 100k residents NC South Carolina: 25,439 units · 473 per 100k residents SC Delaware: 2,187 units · 212 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 9,565 units · 325 per 100k residents MS Alabama: no data reported AL Georgia: 28,176 units · 255 per 100k residents GA D.C.: no data reported DC Hawaii: 1,110 units · 77.4 per 100k residents HI Texas: 56,748 units · 186 per 100k residents TX Florida: 17,119 units · 75.7 per 100k residents FL
Units reimbursed · per 100k residents
51.31,818
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 1,818 /100k
2 South Dakota 1,740 /100k
3 New York 1,404 /100k
4 California 1,365 /100k
5 Wisconsin 1,219 /100k
6 Ohio 1,030 /100k
7 Connecticut 847 /100k
8 Tennessee 699 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Benzonatate — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Benzonatate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$654.6K
Claims incl. refills
49.4K
Beneficiaries
42.4K
Spend / beneficiary
$15.42
Spend / claim
$13.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
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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.