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Benzonatate 100 mg Capsule, Liquid Filled, 500-count — NDC 68382-0247-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Benzonatate 100 mg Capsule, Liquid Filled, 500-count — NDC 68382-247-05 (Billing 68382-0247-05)

by Zydus Pharmaceuticals USA Inc. · 500 CAPSULE in 1 BOTTLE

This is a package of 500 capsules of Benzonatate 100 mg Capsule, Liquid Filled from Zydus Pharmaceuticals USA Inc., marketed since Apr 2007 and currently FDA-listed; retail pharmacies pay about $0.0656 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 68382-0247-05
🏷️ FDA NDC (as labeled) 68382-247-05 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0656 NADAC Per package$32.80 / 500 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3965/unit — full pricing hub ↓
Main listing for product 68382-247 · Also comes in: 100 capsules 68382-247-01
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) 68382-247-05
Product NDC 68382-247
11-digit billing NDC 68382024705
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 43102010000105
GCN Seq No 004641
GCN 29840
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 100 MG CAPSULE
FDB brand name Benzonatate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004641
  • GCN: 29840
  • GPI-14 (Medi-Span): 43102010000105
  • HICL (First Databank): 001929
  • AHFS class code: 48:08.00.00
  • RxCUI (RxNorm): 197397
Why two NDCs? The FDA registers this code as 68382-247-05 — 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 → 68382-0247-05. 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 100 MG CAPSULE Ingredient Benzonatate
📗 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 $0.066 $32.80 / 500 capsules
Medicaid paysCMS SDUD · 12 mo $0.3965 $198.25 / 500 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 $0.094 $0.066
▼ Down 25% 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 Per unit Per pack Marketing startMarketing endStatus
68382-0247-01 68382-247-01 100 CAPSULE in 1 BOTTLE $0.0656 / ea $6.56 2007-04-09 — Active
68382-0247-05 You're viewing this Main listing 500 CAPSULE in 1 BOTTLE $0.0656 / ea $32.80 2007-04-09 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0656 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 66% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 capsule in 1 bottle.
How does this package differ from NDC 68382-0247-01?
Both are Benzonatate 100 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 500-count one, while NDC 68382-0247-01 is the 100 capsules package.
What NDC number is used to bill for this package of Benzonatate 100 mg Capsule, Liquid Filled?
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
Benzonatate 100 mg 00904-6564-60 Major 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 00904-7153-61 Major 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 23155-0898-01 Heritage 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 31722-0956-01 Camber 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 42806-0714-01 Epic 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 49483-0946-01 TIME 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 62135-0440-31 Chartwell 300 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 64380-0712-06 Strides 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 64980-0634-01 Rising 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 67877-0573-01 Ascend 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 68084-0214-01 American 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mgthis 68382-0247-05 Zydus 500 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 69452-0143-20 Bionpharma 100 capsules $0.066 AA Availability likely —
Benzonatate 100 mg 51224-0010-50 TAGI 100 capsules $0.083 AA FDA listed +27%
Benzonatate 100 mg 00615-8403-39 NCS 30 capsules — AA FDA listed —
Benzonatate 100 mg 25000-0002-03 MARKSANS 30 capsules — AA FDA listed —
Benzonatate 100 mg 42291-0091-01 AvKARE 100 capsules — AA FDA listed —
Benzonatate 100 mg 50090-4968-00 A-S 15 capsules — AA FDA listed —
Benzonatate 100 mg 50090-4969-00 A-S 20 capsules — AA FDA listed —
Benzonatate 100 mg 50090-5409-00 A-S 20 capsules — AA FDA listed —
Benzonatate 100 mg 50090-5986-00 A-S 15 capsules — AA FDA listed —
Benzonatate 100 mg 50090-6387-00 A-S 20 capsules — AA FDA listed —
Benzonatate 100 mg 50090-6850-00 A-S 15 capsules — AA FDA listed —
Benzonatate 100 mg 51655-0754-20 Northwind 20 capsules — AA FDA listed —
Benzonatate 100 mg 55154-3372-00 Cardinal 10 capsules — AA FDA listed —
Benzonatate 100 mg 60429-0927-01 Golden 100 capsules — AA FDA listed —
Benzonatate 100 mg 60760-0700-30 St. 30 capsules — AA FDA listed —
Benzonatate 100 mg 60760-0869-15 St. 15 capsules — AA FDA listed —
Benzonatate 100 mg 61919-0400-20 DIRECT 20 capsules — AA FDA listed —
Benzonatate 100 mg 63187-0076-14 Proficient 14 capsules — AA FDA listed —
Benzonatate 100 mg 63187-0799-14 Proficient 14 capsules — AA FDA listed —
benzonatate 100 mg 63187-0928-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 100 mg 63629-2473-01 Bryant 500 capsules — AA FDA listed —
Benzonatate 100 mg 63629-2474-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 100 mg 63629-9189-01 Bryant 500 capsules — AA FDA listed —
Benzonatate 100 mg 65162-0536-10 Amneal 100 capsules — AA FDA listed —
Benzonatate 100 mg 65841-0614-01 Zydus 100 capsules — AA FDA listed —
Benzonatate 100 mg 67046-1484-03 Coupler 30 capsules — AA FDA listed —
Benzonatate 100 mg 67046-1629-03 Coupler 30 capsules — AA FDA listed —
Benzonatate 100 mg 67296-2194-01 Redpharm 15 capsules — AA FDA listed —
Benzonatate 100 mg 67296-2207-01 Redpharm 15 capsules — AA FDA listed —
Benzonatate 100 mg 68071-5083-03 NuCare 30 capsules — AA FDA listed —
Benzonatate 100 mg 68071-5105-04 NuCare 4 capsules — AA FDA listed —
Benzonatate 100 mg 68071-5156-02 NuCare 20 capsules — AA FDA listed —
Benzonatate 100 mg 68071-5223-04 NuCare 4 capsules — AA FDA listed —
Benzonatate 100 mg 68094-0798-50 Precision 100 capsules — AA FDA listed —
Benzonatate 100 mg 68788-7607-00 Preferred 9 capsules — AA FDA listed —
Benzonatate 100 mg 70518-2873-00 REMEDYREPACK 10 capsules — AA FDA listed —
Benzonatate 100 mg 70518-4558-00 REMEDYREPACK 30 capsules — AA FDA listed —
Benzonatate 100 mg 71205-0067-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 100 mg 71205-0632-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 100 mg 71205-0699-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 100 mg 71205-0853-00 Proficient 100 capsules — AA FDA listed —
benzonatate 100 mg 71205-0971-00 Proficient 100 capsules — AA FDA listed —
Benzonatate 100 mg 71335-0091-00 Bryant 10 capsules — AA FDA listed —
benzonatate 100 mg 71335-0688-00 Bryant 10 capsules — AA FDA listed —
benzonatate 100 mg 71335-1329-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71335-1544-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71335-1927-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71335-1968-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71335-2672-01 Bryant 500 capsules — AA FDA listed —
Benzonatate 100 mg 71335-3068-00 Bryant 10 capsules — AA FDA listed —
Benzonatate 100 mg 71610-0692-30 Aphena 30 capsules — AA FDA listed —
Benzonatate 100 mg 72162-1561-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 100 mg 72189-0194-20 DIRECT 20 capsules — AA FDA listed —
Benzonatate 100 mg 72789-0230-06 PD-Rx 6 capsules — AA FDA listed —
Benzonatate 100 mg 72789-0231-15 PD-Rx 15 capsules — AA FDA listed —
Benzonatate 100 mg 72865-0117-01 XLCare 100 capsules — AA FDA listed —
Benzonatate 100 mg 76420-0803-01 Asclemed 100 capsules — AA FDA listed —
Benzonatate 100 mg 85766-0066-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 100 mg 85766-0089-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 100 mg 00615-8661-05 NCS 15 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.

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 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
71.5K
Units reimbursed last 4 qtrs
2.1M
Gross reimbursed last 4 qtrs
$821K
Avg / prescription
$11.49
Avg / unit
$0.3965
Latest quarter Q4 2025
15.1KRx
Medicaid pays / ea
$0.3965
gross reimbursed
vs
NADAC / ea
$0.0656
acquisition cost
=
Spread
+$0.3309
+504% 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 ⓘ
60% FFS 40% MCO
Fee-for-service · 43,094 Rx Managed care · 28,380 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,099 units · 78.8 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: 302 units · 26.7 per 100k residents MT North Dakota: 2,594 units · 331 per 100k residents ND Minnesota: 5,659 units · 98.6 per 100k residents MN Wisconsin: 24,649 units · 417 per 100k residents WI Michigan: 10,004 units · 99.7 per 100k residents MI New York: 98,115 units · 501 per 100k residents NY Vermont: 1,238 units · 191 per 100k residents VT New Hampshire: no data reported NH Oregon: 3,194 units · 75.5 per 100k residents OR Nevada: 6,323 units · 198 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,437 units · 156 per 100k residents SD Iowa: no data reported IA Illinois: 6,620 units · 52.8 per 100k residents IL Indiana: 4,896 units · 71.3 per 100k residents IN Ohio: 50,842 units · 431 per 100k residents OH Pennsylvania: 34,464 units · 266 per 100k residents PA New Jersey: 11,770 units · 127 per 100k residents NJ Massachusetts: no data reported MA California: 1,209,919 units · 3,105 per 100k residents CA Utah: no data reported UT Colorado: 3,433 units · 58.4 per 100k residents CO Nebraska: 6,025 units · 305 per 100k residents NE Missouri: 5,998 units · 96.8 per 100k residents MO Kentucky: 22,200 units · 490 per 100k residents KY West Virginia: 14,348 units · 811 per 100k residents WV Virginia: 146,125 units · 1,677 per 100k residents VA Maryland: 182,883 units · 2,959 per 100k residents MD Connecticut: 4,023 units · 111 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 12,041 units · 570 per 100k residents NM Kansas: no data reported KS Arkansas: 2,087 units · 68.0 per 100k residents AR Tennessee: 7,393 units · 104 per 100k residents TN North Carolina: 2,726 units · 25.2 per 100k residents NC South Carolina: 4,279 units · 79.6 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 3,507 units · 119 per 100k residents MS Alabama: no data reported AL Georgia: 1,472 units · 13.3 per 100k residents GA D.C.: 1,528 units · 225 per 100k residents DC Hawaii: 4,462 units · 311 per 100k residents HI Texas: 27,301 units · 89.5 per 100k residents TX Florida: 301 units · 1.3 per 100k residents FL
Units reimbursed · per 100k residents
1.33,105
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 California 3,105 /100k
2 Maryland 2,959 /100k
3 Virginia 1,677 /100k
4 West Virginia 811 /100k
5 New Mexico 570 /100k
6 New York 501 /100k
7 Kentucky 490 /100k
8 Ohio 431 /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.

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.
500 capsules this page68382-0247-05 71,474 Rx · $820,961
100 capsules68382-0247-01 37,042 Rx · $419,547
Drug total (last 4 qtrs): 108,516 Rx · 3,246,330 units · $1,240,508 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.
← 68382-0227-05 · Zydus 68382-0255-01 · 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.