Benzonatate 100 mg Capsule, 15-count
by NCS HealthCare of KY, LLC dba Vangard Labs · 15 CAPSULE in 1 BLISTER PACK (0615-8661-05)
NDC 00615-8661-05
🏷️ FDA NDC (as labeled)
0615-8661-05
billing pads the labeler segment with a zero
This package
Contains15-count
Pack sizes3 compare ↓
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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)
0615-8661-05
Product NDC
0615-8661
11-digit billing NDC
00615866105
Application #
ANDA202765
SPL Set ID
acf1f48c-15a1-431d-ab80-19587a7008ba
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
2024-07-26
Route
ORAL
Dosage form
CAPSULE
Substance
BENZONATATE
TE code (Orange Book)
AA · RLD · RS
Why two NDCs?
The FDA registers this code as 0615-8661-05 — a 4-4-2 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 labeler segment → 00615-8661-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏭 Manufacturer & labeler
LabelerNCS HealthCare of KY, LLC dba Vangard Labs
Application holderCSPC-NBP PHARMACEUTICAL CO LTD
FDA applicationANDA202765 (ANDA)
Labeler code00615
First marketedJul 2024
Product typeHuman Prescription Drug
Portfolio326 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
📗 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Benzonatate — tap one for details:
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.
💬 Questions about Benzonatate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
yellow
ShapeOval
Imprint1
Size8 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 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.
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 system | Per each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Benzonatate 100 mg 62135-0440-31 | Chartwell | 300 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 68382-0247-01 | Zydus | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 23155-0898-01 | Heritage | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 64980-0634-01 | Rising | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 69452-0143-20 | Bionpharma | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 64380-0712-06 | Strides | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 00904-6564-60 | Major | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 67877-0573-01 | Ascend | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 68084-0214-01 | American | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 00904-7153-61 | Major | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 31722-0956-01 | Camber | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 42806-0714-01 | Epic | 100 capsules | $0.066 | AA | Availability likely | — |
| Benzonatate 100 mg 51224-0010-50 | TAGI | 100 capsules | $0.083 | 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 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 71335-1329-00 | Bryant | 10 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 50090-4968-00 | A-S | 15 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 50090-6850-00 | A-S | 15 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 60760-0700-30 | St. | 30 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 63629-9189-01 | Bryant | 500 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 60429-0927-01 | Golden | 100 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 68071-5156-02 | NuCare | 20 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 50090-6387-00 | A-S | 20 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 61919-0400-20 | DIRECT | 20 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 65841-0614-01 | Zydus | 100 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 68788-7607-00 | Preferred | 9 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 71335-1968-00 | Bryant | 10 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 72189-0194-20 | DIRECT | 20 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 72865-0117-01 | XLCare | 100 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 50090-4969-00 | A-S | 20 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 67296-2194-01 | Redpharm | 15 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 68071-5083-03 | NuCare | 30 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 65162-0536-10 | Amneal | 100 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 68071-5105-04 | NuCare | 4 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 72789-0231-15 | PD-Rx | 15 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 00615-8403-39 | NCS | 30 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 42291-0091-01 | AvKARE | 100 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 55154-3372-00 | Cardinal | 10 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 70518-4558-00 | REMEDYREPACK | 30 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 67296-2207-01 | Redpharm | 15 capsules | — | AA | FDA listed | — |
| benzonatate 100 mg 71335-0688-00 | Bryant | 10 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 71335-1927-00 | Bryant | 10 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 72789-0230-06 | PD-Rx | 6 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 60760-0869-15 | St. | 15 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 51655-0754-20 | Northwind | 20 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 67046-1629-03 | Coupler | 30 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 68094-0798-50 | Precision | 100 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 70518-2873-00 | REMEDYREPACK | 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 85766-0089-01 | Sportpharm | 100 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 67046-1484-03 | Coupler | 30 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 68071-5223-04 | NuCare | 4 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 71335-0091-00 | Bryant | 10 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 71335-1544-00 | Bryant | 10 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mg 49483-0946-01 | TIME | 100 capsules | — | AA | FDA listed | — |
| Benzonatate 100 mgthis 00615-8661-05 | NCS | 15 capsules | — | AA | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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.
📊 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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00615-8661-05 You're viewing this | 15 CAPSULE in 1 BLISTER PACK (0615-8661-05) | 2026-09-15 | Active |
| 00615-8661-21 | 21 CAPSULE in 1 BLISTER PACK (0615-8661-21) | 2026-09-15 | Active |
| 00615-8661-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8661-39) | 2026-09-15 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 00615-8661-05?
NDC 00615-8661-05 is a 15-count package — 15 capsule in 1 blister pack.
What is the difference between NDC 00615-8661-05 and NDC 00615-8661-21?
Both are Benzonatate 100 mg Capsule — the drug itself is identical. NDC 00615-8661-05 is the 15-count package, while NDC 00615-8661-21 is the 21 capsules package.
What NDC number is used to bill for this package of Benzonatate 100 mg Capsule?
Bill NDC 00615-8661-05 — the 11-digit billing format is 00615866105. 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 0615-8661-05, 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: 00615-8661-05, written without dashes as 00615866105. 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 00615-8661-05, the first segment (00615) is the labeler code FDA assigned to NCS HealthCare of KY, LLC dba Vangard Labs; the middle segment (8661) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 NCS HealthCare of KY, LLC dba Vangard Labs. 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 2 other package presentations of this same product, including 21 capsules (00615-8661-21), 30 capsules (00615-8661-39). 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?
NCS HealthCare of KY, LLC dba Vangard Labs 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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.