Medicine
Acetaminophen, Butalbital, Caffeine and Codeine 325 mg/50 mg/40 mg/30 mg capsule
Acetaminophen, Butalbital, Caffeine and Codeine 325 mg/50 mg/40 mg/30 mg capsule is a generic prescription medicine for oral use, made by 5 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 below 30°C (86°F), and dispense in a tight container. Store Butalbital…
Key facts
- Active ingredient (INN)
- Acetaminophen, Butalbital, Caffeine and Codeine
- Brand
- Sold under the generic name
- Strength
- 325 mg/50 mg/40 mg/30 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 20 capsules and 10 more
- Manufacturers
- Bryant Ranch PrepackLGM Pharma SolutionsActavis PharmaBreckenridge PharmaceuticalHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store below 30°C (86°F), and dispense in a tight container. Store Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 September 2003
- Identifiers
- RxCUI 993943, 1431286DailyMed set ID a58819b8-a52c-44a7-9ab0-c74480d98506, 15a34df5-e48f-4570-9232-80e4093c4624, 215e2a6f-ec32-4836-8fad-22c8b40ba1f1 +3NDC 0591-3220, 71335-0194, 72162-1591 +3Application NDA020232, ANDA076560, ANDA215138
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 |
|---|---|---|---|
| 100 capsule in 1 bottle | 0591-3220-01 | Actavis Pharma | 18 September 2003 |
| 100 capsule in 1 bottle, plastic | 51991-073-01 | Breckenridge Pharmaceutical | 1 July 2004 |
| 100 capsule in 1 bottle | 0054-3000-01 | Hikma Pharmaceuticals | 9 May 2022 |
| 100 capsule in 1 bottle, plastic | 79739-6670-1 | LGM Pharma Solutions | 10 June 2004 |
| 500 capsule in 1 bottle, plastic | 79739-6670-5 | LGM Pharma Solutions | 10 June 2004 |
| 20 capsule in 1 bottle | 71335-0194-1 | Bryant Ranch Prepack | 27 December 2021 |
| 90 capsule in 1 bottle | 71335-0194-2 | Bryant Ranch Prepack | 30 August 2019 |
| 30 capsule in 1 bottle | 71335-0194-3 | Bryant Ranch Prepack | 27 December 2021 |
| 60 capsule in 1 bottle | 71335-0194-4 | Bryant Ranch Prepack | 13 December 2021 |
| 100 capsule in 1 bottle | 71335-0194-5 | Bryant Ranch Prepack | 27 December 2021 |
| 15 capsule in 1 bottle | 71335-0194-6 | Bryant Ranch Prepack | 27 December 2021 |
| 18 capsule in 1 bottle | 71335-0194-7 | Bryant Ranch Prepack | 27 December 2021 |
| 20 capsule in 1 bottle, plastic | 72162-1591-2 | Bryant Ranch Prepack | 4 April 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 30 July 1992 | 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 Acetaminophen, Butalbital, Caffeine and Codeine
Clinical summary
Acetaminophen, Butalbital, Caffeine and Codeine is a fixed-dose combination of a barbiturate, a central nervous system stimulant and a methylxanthine. It is available as capsules for oral use. MedsAcross supplies Acetaminophen, Butalbital, Caffeine and Codeine 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, Caffeine and CodeineFor 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, Caffeine, and Codeine Phosphate prescribing information (Actavis Pharma) · U.S. National Library of Medicine, DailyMed
Need Acetaminophen, Butalbital, Caffeine and Codeine 325 mg/50 mg/40 mg/30 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.