Medicine
Fioricet 300 mg/50 mg/40 mg capsule
Fioricet 300 mg/50 mg/40 mg capsule is a prescription medicine containing Acetaminophen, Butalbital and Caffeine for oral use, marketed by Actavis Pharma, 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 o to 25 • C (68 o to 77 • F) Dispense in a tight, light-resistant…
Key facts
- Active ingredient (INN)
- Acetaminophen, Butalbital and Caffeine
- Brand
- Fioricet
- Strength
- 300 mg/50 mg/40 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules
- Marketing authorisation holder
- Actavis Pharma
- Manufacturer
- Actavis Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20 o to 25 • C (68 o to 77 • F) Dispense in a tight, light-resistant container.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 July 2013
- Identifiers
- RxCUI 889520, 1432261DailyMed set ID c018be7d-f7b8-45e2-97b8-8e7a71740657NDC 52544-080Application ANDA040885
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 52544-080-01 | Actavis Pharma | 29 July 2013 |
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 | Approved | 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
Alternatives
Other makers and brands of Acetaminophen, Butalbital and Caffeine 300 mg/50 mg/40 mg capsule.
Other strengths and forms of Acetaminophen, Butalbital and Caffeine
Clinical summary
Acetaminophen, Butalbital and Caffeine is a fixed-dose combination of a barbiturate, a central nervous system stimulant and a methylxanthine indicated for the relief of the symptom complex of tension (or muscle contraction) headache. MedsAcross supplies Acetaminophen, Butalbital and Caffeine 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 Acetaminophen, Butalbital and CaffeineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Butalbital, Acetaminophen and Caffeine prescribing information (Genus Lifesciences) · U.S. National Library of Medicine, DailyMed
Need Fioricet 300 mg/50 mg/40 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.