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Benzonatate 100 mg 100 mg Capsule, Liquid Filled, 500-count — NDC 49483-0946-50 package photo

Benzonatate 100 mg 100 mg Capsule, Liquid Filled, 500-count

by TIME CAP LABORATORIES, INC · 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-50)
NDC 49483-0946-50
🏷️ FDA NDC (as labeled) 49483-946-50 billing pads the product segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Also comes in: 100 capsules 49483-0946-01
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 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) 49483-946-50
Product NDC 49483-946
11-digit billing NDC 49483094650
Application # ANDA220298
SPL Set ID 5adfd324-b6d6-f624-e063-6294a90ab26e
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 2026-09-14
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance BENZONATATE
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
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 49483-946-50 — 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 → 49483-0946-50. 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.

🏭 Manufacturer & labeler

LabelerTIME CAP LABORATORIES, INC
Application holderMARKSANS PHARMA LTD
FDA applicationANDA220298 (ANDA)
Labeler code49483
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio30 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 100 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
Imprint137
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 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 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 MB5IUD6JUA
    Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
  • UNII 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • 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 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.

8 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 mLPer 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.
Try another pack size: 100 capsules
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 100 mg 00904-6564-60 Major 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 00904-7153-61 Major 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 23155-0898-01 Heritage 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 31722-0956-01 Camber 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 42806-0714-01 Epic 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 62135-0440-31 Chartwell 300 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 64380-0712-06 Strides 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 64980-0634-01 Rising 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 67877-0573-01 Ascend 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 68084-0214-01 American 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 68382-0247-01 Zydus 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 69452-0143-20 Bionpharma 100 capsules $0.069 AA Availability likely —
Benzonatate 100 mg 51224-0010-50 TAGI 100 capsules $0.083 AA FDA listed —
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 mgthis 49483-0946-50 TIME 500 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 —
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
Sep 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.

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

Medicare Part D (outpatient prescription) spending for Benzonatate (matched by generic name) — 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 Marketing startStatus
49483-0946-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-01) 2026-09-14 Active
49483-0946-50 You're viewing this 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-50) 2026-09-14 Active

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

Pack size FAQ

What quantity is in NDC 49483-0946-50?
NDC 49483-0946-50 is a 500-count package — 500 capsule, liquid filled in 1 bottle.
What is the difference between NDC 49483-0946-50 and NDC 49483-0946-01?
Both are Benzonatate 100 mg 100 mg Capsule, Liquid Filled — the drug itself is identical. NDC 49483-0946-50 is the 500-count package, while NDC 49483-0946-01 is the 100 capsules package.
What NDC number is used to bill for this package of Benzonatate 100 mg 100 mg Capsule, Liquid Filled?
Bill NDC 49483-0946-50 — the 11-digit billing format is 49483094650. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 49483-946-50, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49483-0946-50, written without dashes as 49483094650. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 49483-0946-50, the first segment (49483) is the labeler code FDA assigned to TIME CAP LABORATORIES, INC; the middle segment (0946) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) identifies this exact package size and type. Together they name one specific package of one specific product.
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 TIME CAP LABORATORIES, INC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 capsules (49483-0946-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
TIME CAP LABORATORIES, INC 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.

📄 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49483-0732-65 · TIME 49483-0947-01 · TIME →
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.