Medicine
Acetaminophen, Butalbital and Caffeine 325 mg/50 mg/40 mg tablet
Acetaminophen, Butalbital and Caffeine 325 mg/50 mg/40 mg tablet is a generic prescription medicine for oral use, made by 25 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°-25°C (68°-77°F) with excursions permitted between 15°-30°C…
Key facts
- Active ingredient (INN)
- Acetaminophen, Butalbital and Caffeine
- Brand
- Sold under the generic name
- Strength
- 325 mg/50 mg/40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 84 tablets and 168 more
- Manufacturers
- Granules IndiaIndiaBryant Ranch PrepackActavis PharmaKVK-TechLannettLGM Pharma SolutionsMikartQuagen PharmaceuticalsChartwell RX25 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F), dispense in a tight, light resistant container as directed in the USP.
- 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
- 21 January 1987
- Identifiers
- RxCUI 238154DailyMed set ID 2abb9915-edb2-6218-e063-6394a90ad462, f6548126-faa1-4f53-8e0b-bc1b743de04d, 5b918d6b-94b0-4f9a-ab09-6a511b727de0 +37NDC 72189-600, 79739-7320, 63629-8392 +37Application ANDA209587, ANDA200243, ANDA214287 +4
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 25 labelers. The register lists 171 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 70010-149-01 | Granules IndiaIndia | 29 June 2022 |
| 500 tablet in 1 bottle | 70010-149-05 | Granules IndiaIndia | 29 June 2022 |
| 100 tablet in 1 bottle | 0591-3369-01 | Actavis Pharma | 13 December 2007 |
| 500 tablet in 1 bottle | 0591-3369-05 | Actavis Pharma | 13 December 2007 |
| 100 tablet in 1 bottle | 62135-751-01 | Chartwell RX | 25 August 2023 |
| 100 tablet in 1 bottle | 10702-253-01 | KVK-Tech | 26 September 2018 |
| 500 tablet in 1 bottle | 10702-253-50 | KVK-Tech | 29 November 2018 |
| 100 tablet in 1 bottle, plastic | 0527-1695-01 | Lannett | 13 September 2012 |
| 500 tablet in 1 bottle, plastic | 0527-1695-05 | Lannett | 13 September 2012 |
| 100 tablet in 1 bottle | 79739-7320-1 | LGM Pharma Solutions | 1 November 2018 |
| 500 tablet in 1 bottle | 79739-7320-5 | LGM Pharma Solutions | 15 December 2018 |
| 100 tablet in 1 bottle, plastic | 46672-053-10 | Mikart | 21 January 1987 |
| 500 tablet in 1 bottle, plastic | 46672-053-50 | Mikart | 21 January 1987 |
| 100 tablet in 1 bottle, plastic | 70752-142-10 | Quagen Pharmaceuticals | 1 May 2024 |
| 500 tablet in 1 bottle, plastic | 70752-142-14 | Quagen Pharmaceuticals | 1 May 2024 |
| 84 tablet in 1 bottle | 63629-8392-0 | Bryant Ranch Prepack | 29 October 2024 |
| 20 tablet in 1 bottle | 63629-8392-1 | Bryant Ranch Prepack | 29 October 2024 |
| 30 tablet in 1 bottle | 63629-8392-2 | Bryant Ranch Prepack | 9 December 2020 |
| 60 tablet in 1 bottle | 63629-8392-3 | Bryant Ranch Prepack | 9 December 2020 |
| 90 tablet in 1 bottle | 63629-8392-4 | Bryant Ranch Prepack | 20 January 2021 |
| 50 tablet in 1 bottle | 63629-8392-5 | Bryant Ranch Prepack | 29 October 2024 |
| 6 tablet in 1 bottle | 63629-8392-6 | Bryant Ranch Prepack | 29 October 2024 |
| 120 tablet in 1 bottle | 63629-8392-7 | Bryant Ranch Prepack | 29 October 2024 |
| 40 tablet in 1 bottle | 63629-8392-8 | Bryant Ranch Prepack | 29 October 2024 |
| 12 tablet in 1 bottle | 63629-8392-9 | Bryant Ranch Prepack | 8 December 2020 |
| 84 tablet in 1 bottle | 71335-1764-0 | Bryant Ranch Prepack | 2 February 2021 |
| 20 tablet in 1 bottle | 71335-1764-1 | Bryant Ranch Prepack | 2 February 2021 |
| 30 tablet in 1 bottle | 71335-1764-2 | Bryant Ranch Prepack | 2 February 2021 |
| 60 tablet in 1 bottle | 71335-1764-3 | Bryant Ranch Prepack | 2 February 2021 |
| 90 tablet in 1 bottle | 71335-1764-4 | Bryant Ranch Prepack | 2 February 2021 |
| 50 tablet in 1 bottle | 71335-1764-5 | Bryant Ranch Prepack | 2 February 2021 |
| 6 tablet in 1 bottle | 71335-1764-6 | Bryant Ranch Prepack | 2 February 2021 |
| 120 tablet in 1 bottle | 71335-1764-7 | Bryant Ranch Prepack | 2 February 2021 |
| 40 tablet in 1 bottle | 71335-1764-8 | Bryant Ranch Prepack | 2 February 2021 |
| 12 tablet in 1 bottle | 71335-1764-9 | Bryant Ranch Prepack | 2 February 2021 |
| 84 tablet in 1 bottle | 71335-1767-0 | Bryant Ranch Prepack | 18 February 2021 |
| 20 tablet in 1 bottle | 71335-1767-1 | Bryant Ranch Prepack | 18 February 2021 |
| 30 tablet in 1 bottle | 71335-1767-2 | Bryant Ranch Prepack | 18 February 2021 |
| 60 tablet in 1 bottle | 71335-1767-3 | Bryant Ranch Prepack | 18 February 2021 |
| 90 tablet in 1 bottle | 71335-1767-4 | Bryant Ranch Prepack | 18 February 2021 |
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
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 Acetaminophen, Butalbital and Caffeine 325 mg/50 mg/40 mg tablet for your hospital or patient?
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