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BENZONATATE 200 mg Capsule, 100-count — NDC 67877-0575-01 package photo

BENZONATATE 200 mg Capsule, 100-count

by Ascend Laboratories, LLC · 100 CAPSULE in 1 BOTTLE (67877-575-01)
NDC 67877-0575-01
🏷️ FDA NDC (as labeled) 67877-575-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1021 NADAC Per package$10.21 / 100 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3989/unit — full pricing hub ↓
Also comes in: 500 capsules 67877-0575-05
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 67877-575-01
Product NDC 67877-575
11-digit billing NDC 67877057501
NCPDP billing unit EA — each (per item)
RxCUI 197397, 283417
UNII 5P4DHS6ENR
Application # ANDA040627
SPL Set ID 54374c04-63b9-49fa-b6a2-4a711e322d8e
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 2017-03-22
Route ORAL
Dosage form CAPSULE
Substance BENZONATATE
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
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 67877-575-01 — 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 → 67877-0575-01. 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.

🏭 Manufacturer & labeler

LabelerAscend Laboratories, LLC
Application holderTHEPHARMANETWORK LLC
FDA applicationANDA040627 (ANDA)
Labeler code67877
First marketedMar 2017
Product typeHuman Prescription Drug
Portfolio349 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.

🩺 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
  • It works by numbing tiny nerve sensors in your airways and lungs that trigger the urge to cough. Think of it like a local anesthetic for your respiratory system — it quiets those s...
  • What is benzonatate actually doing to stop my cough?
  • This is genuinely one of the most important rules with benzonatate. If you chew, crush, or suck on the capsule, the medication gets released directly in your mouth and throat. It t...
  • Why does my pharmacist keep saying I must swallow it whole?
📖 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.

💊 What it looks like

Color Yellow
ShapeCapsule
Imprint106
Size19 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 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 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.

💲 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 $0.102 $10.21 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.3989 $39.89 / 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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.144 $0.102
▼ Down 23% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benzonatate 200 mg 23155-0899-01 Heritage 100 capsules $0.102 AA Availability likely —
Benzonatate 200 mg 31722-0958-01 Camber 100 capsules $0.102 AA Availability likely —
Benzonatate 200 mg 42806-0715-01 Epic 100 capsules $0.102 AA Availability likely —
Benzonatate 200 mg 62135-0441-31 Chartwell 300 capsules $0.102 AA Availability likely —
Benzonatate 200 mg 64380-0713-06 Strides 100 capsules $0.102 AA Availability likely —
Benzonatate 200 mg 64980-0635-01 Rising 100 capsules $0.102 AA Availability likely —
Benzonatate 200 mgthis 67877-0575-01 Ascend 100 capsules $0.102 AA Availability likely —
Benzonatate 200 mg 68382-0091-01 Zydus 100 capsules $0.102 AA Availability likely —
Benzonatate 200 mg 69452-0144-20 Bionpharma 100 capsules $0.102 AA Availability likely —
Benzonatate 200 mg 51224-0001-50 TAGI 100 capsules $0.120 AA FDA listed +18%
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 49483-0947-01 TIME 100 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

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 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.

🗺️ 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 67877-0575-01, 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
5.3K
Units reimbursed last 4 qtrs
166.8K
Gross reimbursed last 4 qtrs
$66.5K
Avg / prescription
$12.55
Avg / unit
$0.3989
Latest quarter Q4 2025
3.1KRx
Medicaid pays / ea
$0.3989
gross reimbursed
vs
NADAC / ea
$0.1021
acquisition cost
=
Spread
+$0.2968
+291% 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 ⓘ
41% FFS 59% MCO
Fee-for-service · 2,158 Rx Managed care · 3,143 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,136 units · 153 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: 357 units · 31.5 per 100k residents MT North Dakota: no data reported ND Minnesota: 4,208 units · 73.3 per 100k residents MN Wisconsin: 5,880 units · 99.5 per 100k residents WI Michigan: 2,430 units · 24.2 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,856 units · 67.5 per 100k residents OR Nevada: 2,237 units · 70.0 per 100k residents NV Wyoming: no data reported WY South Dakota: 283 units · 30.8 per 100k residents SD Iowa: no data reported IA Illinois: 1,424 units · 11.3 per 100k residents IL Indiana: 10,444 units · 152 per 100k residents IN Ohio: 12,704 units · 108 per 100k residents OH Pennsylvania: 13,108 units · 101 per 100k residents PA New Jersey: 2,945 units · 31.7 per 100k residents NJ Massachusetts: no data reported MA California: 38,261 units · 98.2 per 100k residents CA Utah: 2,239 units · 65.5 per 100k residents UT Colorado: 938 units · 16.0 per 100k residents CO Nebraska: 995 units · 50.3 per 100k residents NE Missouri: 10,347 units · 167 per 100k residents MO Kentucky: 10,333 units · 228 per 100k residents KY West Virginia: 5,459 units · 308 per 100k residents WV Virginia: 10,369 units · 119 per 100k residents VA Maryland: 3,846 units · 62.2 per 100k residents MD Connecticut: 2,040 units · 56.4 per 100k residents CT Rhode Island: no data reported RI Arizona: 6,151 units · 82.8 per 100k residents AZ New Mexico: 2,030 units · 96.0 per 100k residents NM Kansas: 422 units · 14.4 per 100k residents KS Arkansas: no data reported AR Tennessee: 3,428 units · 48.1 per 100k residents TN North Carolina: no data reported NC South Carolina: 2,918 units · 54.3 per 100k residents SC Delaware: 387 units · 37.5 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 1,482 units · 50.4 per 100k residents MS Alabama: no data reported AL Georgia: 2,046 units · 18.6 per 100k residents GA D.C.: no data reported DC Hawaii: 1,635 units · 114 per 100k residents HI Texas: no data reported TX Florida: 454 units · 2.0 per 100k residents FL
Units reimbursed · per 100k residents
2.0308
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 308 /100k
2 Kentucky 228 /100k
3 Missouri 167 /100k
4 Maine 153 /100k
5 Indiana 152 /100k
6 Virginia 119 /100k
7 Hawaii 114 /100k
8 Ohio 108 /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 capsules67877-0575-05 15,649 Rx · $185,018
100 capsules this page67877-0575-01 5,301 Rx · $66,540
Drug total (last 4 qtrs): 20,950 Rx · 618,408 units · $251,558 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
67877-0575-01 You're viewing this 100 CAPSULE in 1 BOTTLE (67877-575-01) $0.1021 / ea $10.21 2017-03-22 Active
67877-0575-05 500 CAPSULE in 1 BOTTLE (67877-575-05) $0.1021 / ea $51.04 2017-03-22 Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1021 NADAC).

This pack accounts for about 25% of this product's recent Medicaid fills; most go to the 500 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 67877-0575-01?
NDC 67877-0575-01 is a 100-count package — 100 capsule in 1 bottle.
What is the difference between NDC 67877-0575-01 and NDC 67877-0575-05?
Both are BENZONATATE 200 mg Capsule — the drug itself is identical. NDC 67877-0575-01 is the 100-count package, while NDC 67877-0575-05 is the 500 capsules package.
What NDC number is used to bill for this package of BENZONATATE 200 mg Capsule?
Bill NDC 67877-0575-01 — the 11-digit billing format is 67877057501. 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.

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 13 words ▾

INDICATIONS & USAGE Benzonatate USP is indicated for the symptomatic relief of cough.

⏱️ Dosage and Administration 66 words ▾

DOSAGE & ADMINISTRATION Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 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 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 132 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 capsules 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 76 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.

🤰 Pregnancy 49 words ▾

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.

🧒 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 209 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 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 113 words ▾

HOW SUPPLIED Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted “105”, available in bottles of 100’s (NDC 67877-573-01), and 500’s (NDC 67877-573-05). Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted "128", available in bottles of 100 (NDC 67877-574-01). Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted “106”, available in bottles of 100’s (NDC 67877-575-01) and 500’s (NDC 67877-575-05).

Store at 20°C to 25° C (68°F to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT . Manufactured by: Softgel Healthcare Pvt.

Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam, Chengalpattu, Tamilnadu - 603 103, India. Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921 Revised: November 2025 PT3732-01 (2411326)

📋 Description 63 words ▾

DESCRIPTION Benzonatate, 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 soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben and propylparaben. structure

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