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Benzonatate 200 mg Capsule, 100-count — NDC 65841-0843-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Benzonatate 200 mg Capsule, 100-count — NDC 65841-843-01 (Billing 65841-0843-01)

by Zydus Lifesciences Limited · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Benzonatate 200 mg Capsule from Zydus Lifesciences Limited, marketed since Sep 2007 and currently FDA-listed. It is this product's only package size.

NDC 65841-0843-01
🏷️ FDA NDC (as labeled) 65841-843-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Benzonatate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Dec 26, 2023 — Superpotent drug: Assay results were slightly above specification at the time zero point. (Amerisource Health Services LLC) · FDA recall D-0257-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65841-843-01
Product NDC 65841-843
11-digit billing NDC 65841084301
RxCUI 197397, 283417
UNII 5P4DHS6ENR
Application # ANDA040597
SPL Set ID abb4360a-4c52-45b6-9b80-df3c1bfc4c59
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 2007-09-04
Route ORAL
Dosage form CAPSULE
Substance BENZONATATE
TE code (Orange Book) AA · RLD · RS
Quick answers
  • RxCUI (RxNorm): 197397
Why two NDCs? The FDA registers this code as 65841-843-01 — 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 → 65841-0843-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Non-narcotic Antitussive class.

Pharmacologic class Non-narcotic Antitussive
Drug family (ATC) Other cough suppressants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No, benzonatate is not related to codeine or narcotic cough medicines. Instead of working on your brain, it acts more like a local anesthetic inside your airways — it numbs the ner...
  • What exactly does benzonatate do — is it like cough syrup with codeine?
  • This is one of the most important things to know about benzonatate. The medicine inside acts like a numbing agent — if the capsule breaks open in your mouth, it can rapidly numb yo...
  • Why does my pharmacist keep telling me not to chew the capsule?
📖 Read our full Benzonatate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65841-0843-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2007-09-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benzonatate 200 mg 23155-0899-01 Heritage 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 31722-0958-01 Camber 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 42806-0715-01 Epic 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 49483-0947-01 TIME 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 62135-0441-31 Chartwell 300 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 64380-0713-06 Strides 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 64980-0635-01 Rising 100 capsules $0.101 AA Availability likely —
Benzonatate 200 mg 67877-0575-01 Ascend 100 capsules $0.101 AA Availability likely —
Benzonatate 200 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 —
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 mgthis 65841-0843-01 Zydus 100 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1464-03 RedPharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1751-03 RedPharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-1833-03 Redpharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2153-01 Redpharm 15 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2202-03 Redpharm 30 capsules — AA FDA listed —
Benzonatate 200 mg 67296-2244-05 Redpharm 15 capsules — AA Discontinued —
Benzonatate 200 mg 68071-1395-03 NuCare 30 capsules — AA FDA listed —
Benzonatate 200 mg 68071-2562-03 NuCare 30 capsules — AA FDA listed —
Benzonatate 200 mg 68094-0901-50 Precision 100 capsules — AA FDA listed —
Benzonatate 200 mg 68788-8329-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mg 68788-8336-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mg 68788-8405-01 Preferred 15 capsules — AA FDA listed —
Benzonatate 200 mg 70518-2491-00 REMEDYREPACK 30 capsules — AA Discontinued —
Benzonatate 200 mg 70518-4182-00 REMEDYREPACK 30 capsules — AA FDA listed —
Benzonatate 200 mg 70518-4497-00 REMEDYREPACK 20 capsules — AA FDA listed —
benzonatate 200 mg 71205-0037-10 Proficient 10 capsules — — FDA listed —
Benzonatate 200 mg 71205-0605-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0643-10 Proficient 10 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0673-06 Proficient 6 capsules — AA FDA listed —
Benzonatate 200 mg 71205-0887-00 Proficient 100 capsules — AA FDA listed —
benzonatate 200 mg 71205-0972-00 Proficient 100 capsules — — FDA listed —
Benzonatate 200 mg 71335-0031-01 Bryant 30 capsules — AA FDA listed —
benzonatate 200 mg 71335-0725-01 Bryant 30 capsules — — FDA listed —
Benzonatate 200 mg 71335-1553-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-1880-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2021-01 Bryant 30 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2486-00 Bryant 6 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2590-00 Bryant 6 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2788-01 Bryant 21 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2790-01 Bryant 21 capsules — AA FDA listed —
Benzonatate 200 mg 71335-2853-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 72162-1316-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 72162-1560-01 Bryant 100 capsules — AA FDA listed —
Benzonatate 200 mg 72189-0192-20 DIRECT 20 capsules — AA FDA listed —
Benzonatate 200 mg 72189-0606-20 Direct_rx 20 capsules — AA FDA listed —
Benzonatate 200 mg 72789-0232-21 PD-Rx 21 capsules — AA FDA listed —
Benzonatate 200 mg 72865-0119-01 XLCare 100 capsules — AA FDA listed —
Benzonatate 200 mg 76420-0804-01 Asclemed 100 capsules — AA FDA listed —
Benzonatate 200 mg 85766-0068-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 200 mg 85766-0090-01 Sportpharm 100 capsules — AA FDA listed —
Benzonatate 200 mg 71335-3169-01 Bryant 21 capsules — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

What it looks like

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

Inactive Ingredients / Excipients

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

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

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

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA040597 (ANDA)
Labeler code65841
First marketedSep 2007
Product typeHuman Prescription Drug
Portfolio720 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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 42 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-614-01 in bottle of 100 capsules Benzonatate Capsules USP, 100 mg R x only 100 capsules NDC 65841-843-01 in bottle of 100 capsules Benzonatate Capsules USP, 200 mg R x only 100 capsules Benzonatate Capsules Benzonatate Capsules

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

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.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 65841-0842-01 · Zydus 65841-0846-14 · 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.