Medicine
Homatropine methylbromide and Hydrocodone 1.5 mg/5 mg per 5 mL oral solution
Homatropine methylbromide and Hydrocodone 1.5 mg/5 mg per 5 mL oral solution is a generic prescription medicine for oral use, made by 2 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 oral solution at controlled room temperature 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Homatropine methylbromide and Hydrocodone
- Brand
- Sold under the generic name
- Strength
- 1.5 mg/5 mg per 5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 4 trays
- Manufacturers
- Genus LifesciencesPAI Pharma
- Origin register
- US FDA, United States
- Storage
- Store oral solution at controlled room temperature 20°C to 25°C (68°F to 77°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
- 10 August 2022
- Identifiers
- RxCUI 992668, 992656DailyMed set ID 71319a6f-aaf4-4bc5-8b40-a16c6f139be6, 320ff639-9854-407b-9bbd-a035c4f173e1NDC 0121-1036, 64950-371Application 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 |
|---|---|---|---|
| 473 mL in 1 bottle | 64950-371-47 | Genus Lifesciences | 10 August 2022 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-1036-40 | PAI Pharma | 5 August 2024 |
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 per 5 mL oral solution 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.