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Benzonatate 200 mg Capsule, 500-count — NDC 64380-0713-07 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, 500-count — NDC 64380-713-07 (Billing 64380-0713-07)

by Strides Pharma Science Limited · 500 CAPSULE in 1 BOTTLE

This is a package of 500 capsules of Benzonatate 200 mg Capsule from Strides Pharma Science Limited, marketed since May 2026 and currently FDA-listed; retail pharmacies pay about $0.1013 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 64380-0713-07
🏷️ FDA NDC (as labeled) 64380-713-07 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.1013 NADAC Per package$50.65 / 500 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.4087/unit — full pricing hub ↓
Main listing for product 64380-713 · Also comes in: 100 capsules 64380-713-06
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 →

NDC database record

One package, one record: these facts belong to NDC 64380-713-07 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
64380 labeler · 713 product · 07 package
Package marketed since
May 29, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
500 EA per package
Barcode (UPC)
0364380713074, 0364380712060, 0364380712077, 0364380713067
Medicaid fills, this package
298,896 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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) 64380-713-07
Product NDC 64380-713
11-digit billing NDC 64380071307
NCPDP billing unit EA — each (per item)
RxCUI 197397, 283417
UNII 5P4DHS6ENR
UPC 0364380713074, 0364380712060, 0364380712077, 0364380713067
Application # ANDA091133
SPL Set ID 89f5d18e-5ef4-42a3-bc6f-abf4f308462b
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 2026-05-29
Route ORAL
Dosage form CAPSULE
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
GPI class Benzonatate
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 64380-713-07 — 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 → 64380-0713-07. 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
📗 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 $50.65 / 500 capsules
Medicaid paysCMS SDUD · 12 mo $0.4087 $204.35 / 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 $0.144 $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 Per unit Per pack Marketing startMarketing endStatus
64380-0713-06 64380-713-06 100 CAPSULE in 1 CONTAINER $0.1013 / ea $10.13 2016-12-10 — Active
64380-0713-07 You're viewing this Main listing 500 CAPSULE in 1 BOTTLE $0.1013 / ea $50.65 2016-12-16 — 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 ($0.1013 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 90% 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 64380-0713-06?
Both are Benzonatate 200 mg Capsule — the drug itself is identical. This page's package is the 500-count one, while NDC 64380-0713-06 is the 100 capsules package.
What NDC number is used to bill for this package of Benzonatate 200 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
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 mgthis 64380-0713-07 Strides 500 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 mg 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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
Imprint704
Size1 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

11 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

LabelerStrides Pharma Science Limited
Application holderONESOURCE SPECIALTY PTE LTD
FDA applicationANDA091133 (ANDA)
Labeler code64380
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio195 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 14 words ▾

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

⏱️ Dosage and Administration 67 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 USP should be swallowed whole . Benzonatate capsules USP are not to be broken, chewed, dissolved, cut or crushed.

⛔ Contraindications 7 words ▾

CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.

⚠️ Warnings 130 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 in combination with other prescribed drugs.

Accidental Ingestion and Death in Children Keep benzonatate out of reach of children. Accidental ingestion of benzonatate 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 97 words ▾

ADVERSE REACTIONS Potential Adverse Reactions to benzonatate 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.

Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825orgo to www.strides.com

🆘 Overdosage 208 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 15-20 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 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 61 words ▾

CLINICAL PHARMACOLOGY Benzonatate acts 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 has no inhibitory effect on the respiratory center in recommended dosage.

📦 How Supplied / Storage and Handling 126 words ▾

HOW SUPPLIED Benzonatate capsules USP, 100 mg are available as yellow colored, oval shaped soft gelatin capsules, imprinted as '705' in white ink and containing clear, pale yellow viscous liquid. NDC 64380-712-06 in bottles of 100 capsules. NDC 64380-712-07 in bottles of 500 capsules.

Benzonatate capsules USP, 200 mg are available as yellow colored, oval shaped soft gelatin capsules, imprinted as ‘704’ in white ink and containing clear, pale yellow viscous liquid. NDC 64380-713-06 in bottles of 100 capsules. NDC 64380-713-07 in bottles of 500 capsules.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature] Protect Form Light. Dispense in a tight (USP), child-resistant containers. Distributed by: Strides Pharma, Inc.

Bridgewater, NJ 08807 Rx Only Revised: 06/2026

📋 Description 83 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 USP, 100 mg contains: Benzonatate USP 100 mg Each benzonatate capsule USP, 200 mg contains: Benzonatate USP 200 mg Benzonatate capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben, propylparaben and purified water. Ingredients of the imprinting ink are: Propylene glycol, shellac resins, sodium lauryl sulphate, isopropyl alcohol and titanium dioxide.

Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Benzonatate is chemically related to anesthetic agents of the para-aminobenzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to 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 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, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.

Usage in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate. It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Benzonatate 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 is administered to a nursing woman.

Carcinogenic, mutagenesis, impairment of fertility: Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate. 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.

📄 Package Label / Principal Display Panel 76 words ▾

Benzonatate Capsule USP, 100mg NDC 64380-712-06 Benzonatate Capsules USP 100mg PROTECT FROM LIGHT Strides Pharma, Inc. 100 Capsules RX only NDC 64380-712-07 Benzonatate Capsules USP 100mg PROTECT FROM LIGHT Strides Pharma, Inc. 500 Capsules RX only Benzonatate-100mg-100cap Benzonatate-100mg-500cap

Benzonatate Capsules USP, 200mg NDC 64380-713-06 Benzonatate Capsules USP 200mg PROTECT FROM LIGHT Strides Pharma, Inc. 100 Capsules RX only NDC 64380-713-07 Benzonatate Capsules USP 200mg PROTECT FROM LIGHT Strides Pharma, Inc. 500 Capsules RX only Benzonatate-200mg-100cap Benzonatate-200mg-500cap.jpg

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 – Q1 2026 · 5 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
298.9K
Units reimbursed last 4 qtrs
8.5M
Gross reimbursed last 4 qtrs
$3.47M
Avg / prescription
$11.61
Avg / unit
$0.4087
Latest quarter Q1 2026
85.9KRx
Medicaid pays / ea
$0.4087
gross reimbursed
vs
NADAC / ea
$0.1013
acquisition cost
=
Spread
+$0.3074
+303% 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 ⓘ
53% FFS 47% MCO
Fee-for-service · 157,779 Rx Managed care · 141,117 Rx
State Medicaid map
Alaska: no data reported AK Maine: 20,605 units · 1,477 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: 12,830 units · 1,133 per 100k residents MT North Dakota: 5,164 units · 660 per 100k residents ND Minnesota: 48,143 units · 839 per 100k residents MN Wisconsin: 64,249 units · 1,087 per 100k residents WI Michigan: 69,531 units · 693 per 100k residents MI New York: 963,542 units · 4,923 per 100k residents NY Vermont: 9,513 units · 1,470 per 100k residents VT New Hampshire: 11,243 units · 802 per 100k residents NH Oregon: 39,637 units · 936 per 100k residents OR Nevada: 149,237 units · 4,672 per 100k residents NV Wyoming: 2,236 units · 383 per 100k residents WY South Dakota: 2,666 units · 290 per 100k residents SD Iowa: no data reported IA Illinois: 95,059 units · 758 per 100k residents IL Indiana: 400,355 units · 5,834 per 100k residents IN Ohio: 423,390 units · 3,593 per 100k residents OH Pennsylvania: 401,554 units · 3,098 per 100k residents PA New Jersey: 223,387 units · 2,405 per 100k residents NJ Massachusetts: 1,684 units · 24.1 per 100k residents MA California: 2,725,653 units · 6,995 per 100k residents CA Utah: 13,500 units · 395 per 100k residents UT Colorado: 24,160 units · 411 per 100k residents CO Nebraska: 11,628 units · 588 per 100k residents NE Missouri: 113,253 units · 1,828 per 100k residents MO Kentucky: 134,564 units · 2,973 per 100k residents KY West Virginia: 118,241 units · 6,680 per 100k residents WV Virginia: 406,850 units · 4,668 per 100k residents VA Maryland: 251,099 units · 4,063 per 100k residents MD Connecticut: 289,384 units · 8,001 per 100k residents CT Rhode Island: 127,747 units · 11,666 per 100k residents RI Arizona: 290,103 units · 3,904 per 100k residents AZ New Mexico: 25,177 units · 1,191 per 100k residents NM Kansas: 7,068 units · 240 per 100k residents KS Arkansas: no data reported AR Tennessee: 85,755 units · 1,203 per 100k residents TN North Carolina: 6,508 units · 60.1 per 100k residents NC South Carolina: 123,724 units · 2,303 per 100k residents SC Delaware: 24,476 units · 2,374 per 100k residents DE Oklahoma: no data reported OK Louisiana: 788 units · 17.2 per 100k residents LA Mississippi: 24,090 units · 819 per 100k residents MS Alabama: no data reported AL Georgia: 83,269 units · 755 per 100k residents GA D.C.: 27,810 units · 4,096 per 100k residents DC Hawaii: 107,217 units · 7,472 per 100k residents HI Texas: 428,907 units · 1,406 per 100k residents TX Florida: 93,883 units · 415 per 100k residents FL
Units reimbursed · per 100k residents
17.211,666
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 Rhode Island 11,666 /100k
2 Connecticut 8,001 /100k
3 Hawaii 7,472 /100k
4 California 6,995 /100k
5 West Virginia 6,680 /100k
6 Indiana 5,834 /100k
7 New York 4,923 /100k
8 Nevada 4,672 /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 page64380-0713-07 298,896 Rx · $3,469,169
100 capsules64380-0713-06 32,407 Rx · $398,760
Drug total (last 4 qtrs): 331,303 Rx · 9,409,257 units · $3,867,929 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.
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.