Medicine
Benzonatate 100 mg capsule
Benzonatate 100 mg capsule is a generic prescription medicine for oral use, made by 36 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Benzonatate
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 30 capsules and 262 more
- Manufacturers
- Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaMarksans PharmaIndiaAscend LaboratoriesIndiaAvet PharmaceuticalsIndiaStrides PharmaIndiaTime Cap LaboratoriesIndiaBryant Ranch PrepackChartwell RXXLCare Pharmaceuticals36 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F). PROTECT FROM LIGHT Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R05DB01 Benzonatate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 January 1993
- Identifiers
- RxCUI 197397, 283417, 903291DailyMed set ID a52856fc-049d-48cf-8cc4-de059850e31a, b46f231a-65d3-400d-ae6b-3216830807a2, 70e157f2-1670-422c-a70d-f9576e1647ea +37NDC 71335-2672, 55154-3372, 72789-230 +37Application ANDA202765, ANDA206948, ANDA040627 +6
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 36 labelers. The register lists 265 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 65841-614-01 | Zydus LifesciencesIndia | 4 September 2007 |
| 500 capsule in 1 bottle | 65841-614-05 | Zydus LifesciencesIndia | 4 September 2007 |
| 100 capsule, liquid filled in 1 bottle | 68382-247-01 | Zydus LifesciencesIndia | 9 April 2007 |
| 500 capsule, liquid filled in 1 bottle | 68382-247-05 | Zydus LifesciencesIndia | 9 April 2007 |
| 100 capsule in 1 bottle | 67877-573-01 | Ascend LaboratoriesIndia | 22 March 2017 |
| 500 capsule in 1 bottle | 67877-573-05 | Ascend LaboratoriesIndia | 22 March 2017 |
| 100 capsule, liquid filled in 1 bottle | 23155-898-01 | Avet PharmaceuticalsIndia | 29 September 2024 |
| 500 capsule, liquid filled in 1 bottle | 23155-898-05 | Avet PharmaceuticalsIndia | 29 September 2024 |
| 100 capsule in 1 bottle | 31722-956-01 | Camber PharmaceuticalsIndia | 22 February 2019 |
| 500 capsule in 1 bottle | 31722-956-05 | Camber PharmaceuticalsIndia | 22 February 2019 |
| 30 capsule in 1 bottle | 31722-956-30 | Camber PharmaceuticalsIndia | 22 February 2019 |
| 30 capsule, liquid filled in 1 bottle | 25000-002-03 | Marksans PharmaIndia | 10 April 2026 |
| 100 capsule, liquid filled in 1 bottle | 25000-002-08 | Marksans PharmaIndia | 10 April 2026 |
| 500 capsule, liquid filled in 1 bottle | 25000-002-12 | Marksans PharmaIndia | 10 April 2026 |
| 100 capsule in 1 container | 64380-712-06 | Strides PharmaIndia | 29 May 2026 |
| 500 capsule in 1 bottle | 64380-712-07 | Strides PharmaIndia | 29 May 2026 |
| 100 capsule, liquid filled in 1 bottle | 49483-946-01 | Time Cap LaboratoriesIndia | 14 September 2026 |
| 500 capsule, liquid filled in 1 bottle | 49483-946-50 | Time Cap LaboratoriesIndia | 14 September 2026 |
| 100 capsule, liquid filled in 1 bottle | 65162-536-10 | Amneal Pharmaceuticals | 4 June 2010 |
| 500 capsule, liquid filled in 1 bottle | 65162-536-50 | Amneal Pharmaceuticals | 4 June 2010 |
| 100 capsule in 1 bottle, plastic | 69452-143-20 | Bionpharma | 15 August 2016 |
| 500 capsule in 1 bottle, plastic | 69452-143-30 | Bionpharma | 15 August 2016 |
| 100 capsule in 1 bottle | 62135-440-01 | Chartwell RX | 22 March 2023 |
| 300 capsule in 1 bottle | 62135-440-31 | Chartwell RX | 5 January 2023 |
| 90 capsule in 1 bottle | 62135-440-90 | Chartwell RX | 5 January 2023 |
| 100 capsule in 1 bottle | 42806-714-01 | Epic Pharma | 21 December 2018 |
| 500 capsule in 1 bottle | 42806-714-05 | Epic Pharma | 21 December 2018 |
| 100 capsule in 1 bottle | 64980-634-01 | Rising Pharma Holdings | 26 July 2024 |
| 500 capsule in 1 bottle | 64980-634-50 | Rising Pharma Holdings | 26 July 2024 |
| 100 capsule in 1 bottle | 51224-010-50 | TAGI Pharma | 7 September 2017 |
| 500 capsule in 1 bottle | 51224-010-60 | TAGI Pharma | 7 September 2017 |
| 100 capsule in 1 bottle | 72865-117-01 | XLCare Pharmaceuticals | 17 February 2020 |
| 500 capsule in 1 bottle | 72865-117-05 | XLCare Pharmaceuticals | 17 February 2020 |
| 30 capsule in 1 bottle | 72865-117-30 | XLCare Pharmaceuticals | 17 February 2020 |
| 500 capsule in 1 bottle | 63629-2473-1 | Bryant Ranch Prepack | 7 September 2017 |
| 100 capsule in 1 bottle | 63629-2474-1 | Bryant Ranch Prepack | 7 September 2017 |
| 500 capsule in 1 bottle | 63629-9189-1 | Bryant Ranch Prepack | 3 August 2022 |
| 10 capsule in 1 bottle | 71335-0091-0 | Bryant Ranch Prepack | 30 April 2019 |
| 30 capsule in 1 bottle | 71335-0091-1 | Bryant Ranch Prepack | 30 April 2019 |
| 20 capsule in 1 bottle | 71335-0091-2 | Bryant Ranch Prepack | 30 April 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 10 February 1958 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Benzonatate
Clinical summary
Benzonatate is a non-narcotic antitussive indicated for the symptomatic relief of cough. It is available as capsules for oral use. MedsAcross supplies Benzonatate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about BenzonatateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Benzonatate 100 mg prescribing information (Time Cap Laboratories) · U.S. National Library of Medicine, DailyMed
Need Benzonatate 100 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.