Medicine
Homatropine methylbromide and Hydrocodone 1.5 mg/5 mg tablet
Homatropine methylbromide and Hydrocodone 1.5 mg/5 mg tablet is a generic prescription medicine for oral use, made by 4 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 tablets at controlled room temperature 20°C to 25°C (68°F to 77°F) with…
Key facts
- Active ingredient (INN)
- Homatropine methylbromide and Hydrocodone
- Brand
- Sold under the generic name
- Strength
- 1.5 mg/5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 500 tablets and 6 more
- Manufacturers
- Novel LaboratoriesIndiaKVK-TechGenus Lifesciences4 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store tablets at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30° C (59° to 86° F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 September 2014
- Identifiers
- RxCUI 992656, 992668DailyMed set ID 26d7c90c-5e6b-4bdb-b06f-c76173a01c21, 41ac90b3-f007-4eb2-9d41-ea626ced2017, 320ff639-9854-407b-9bbd-a035c4f173e1 +1NDC 10702-055, 43386-118, 64950-206 +1Application ANDA207176, ANDA091528, NDA005213
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 40032-118-03 | Novel LaboratoriesIndia | 23 September 2014 |
| 100 tablet in 1 bottle | 40032-118-24 | Novel LaboratoriesIndia | 23 September 2014 |
| 500 tablet in 1 bottle | 40032-118-26 | Novel LaboratoriesIndia | 23 September 2014 |
| 30 tablet in 1 bottle, plastic | 64950-206-03 | Genus Lifesciences | 10 August 2022 |
| 100 tablet in 1 bottle, plastic | 64950-206-10 | Genus Lifesciences | 10 August 2022 |
| 100 tablet in 1 bottle | 10702-055-01 | KVK-Tech | 7 August 2017 |
| 30 tablet in 1 bottle | 10702-055-03 | KVK-Tech | 7 August 2017 |
| 90 tablet in 1 bottle | 10702-055-09 | KVK-Tech | 7 August 2017 |
| 1000 tablet in 1 bottle | 10702-055-10 | KVK-Tech | 7 August 2017 |
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 23 March 1943 | 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 Homatropine methylbromide and Hydrocodone
Clinical summary
Homatropine methylbromide and Hydrocodone is a fixed-dose combination medicine indicated for the symptomatic relief of cough in adult patients 18 years of age and older, among other approved uses. MedsAcross supplies Homatropine methylbromide and Hydrocodone 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 Homatropine methylbromide and HydrocodoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hydrocodone Bitartrate and Homatropine Methylbromide prescribing information (Genus Lifesciences) · U.S. National Library of Medicine, DailyMed
Need Homatropine methylbromide and Hydrocodone 1.5 mg/5 mg tablet 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.