Medicine
Acetaminophen, Butalbital and Caffeine 325 mg/50 mg/40 mg capsule
Acetaminophen, Butalbital and Caffeine 325 mg/50 mg/40 mg capsule is a generic prescription medicine for oral use, made by 7 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 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Acetaminophen, Butalbital and Caffeine
- Brand
- Sold under the generic name
- Strength
- 325 mg/50 mg/40 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 30 capsules and 9 more
- Manufacturers
- Aurolife PharmaIndiaDr. Reddy's LaboratoriesIndiaBryant Ranch PrepackQuagen PharmaceuticalsAmici PharmaLannettSeton Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°F).
- 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
- 26 April 2017
- Identifiers
- RxCUI 238153, 889520DailyMed set ID 8a4cf981-37f7-4bc9-a9d7-b134a5fd0894, c1107153-494b-4068-8500-96bc241187a5, 69df02fa-c842-48dc-7ac6-5967b7dc30de +6NDC 72162-2665, 0527-4094, 75907-009 +6Application ANDA216376, ANDA212083, ANDA089007 +2
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 | 13107-075-01 | Aurolife PharmaIndia | 26 April 2017 |
| 500 capsule in 1 bottle | 13107-075-05 | Aurolife PharmaIndia | 26 April 2017 |
| 30 capsule in 1 bottle | 13107-075-30 | Aurolife PharmaIndia | 26 April 2017 |
| 100 capsule in 1 bottle, plastic | 75907-009-01 | Dr. Reddy's LaboratoriesIndia | 1 September 2024 |
| 100 capsule in 1 bottle | 69292-305-01 | Amici Pharma | 10 April 2026 |
| 100 capsule in 1 bottle, plastic | 0527-4094-37 | Lannett | 17 December 2019 |
| 100 capsule in 1 bottle, plastic | 70752-141-10 | Quagen Pharmaceuticals | 6 August 2022 |
| 500 capsule in 1 bottle, plastic | 70752-141-14 | Quagen Pharmaceuticals | 6 August 2022 |
| 100 capsule in 1 bottle | 13925-536-01 | Seton Pharmaceuticals | 2 March 2022 |
| 100 capsule in 1 bottle, plastic | 63629-2087-1 | Bryant Ranch Prepack | 2 June 2021 |
| 100 capsule in 1 bottle, plastic | 72162-1096-1 | Bryant Ranch Prepack | 31 January 2024 |
| 100 capsule in 1 bottle, plastic | 72162-2665-1 | Bryant Ranch Prepack | 13 July 2026 |
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 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.