Medicine
Acetaminophen and Butalbital 325 mg/50 mg tablet
Acetaminophen and Butalbital 325 mg/50 mg tablet 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 butalbital and acetaminophen tablets at 25°C (77°F), excursions…
Key facts
- Active ingredient (INN)
- Acetaminophen and Butalbital
- Brand
- Sold under the generic name
- Strength
- 325 mg/50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 500 tablets and 4 more
- Manufacturers
- Larken LaboratoriesQuagen PharmaceuticalsAmici PharmaBurel PharmaceuticalsPar Health
- Origin register
- US FDA, United States
- Storage
- Store butalbital and acetaminophen tablets at 25°C (77°F), excursions permitted to 15°C-30°C (59°F-86°F). Protect from light and moisture.
- 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
- 3 June 1999
- Identifiers
- RxCUI 197426, 1249617, 1724446 +1DailyMed set ID 0a8a6a16-b23f-45d2-b5d4-540264e74d14, 326c83fc-afed-45ad-9c87-f47968fa1d2a, 2eb09253-7f59-401e-afbc-70bb9600fedf +2NDC 35573-456, 68047-721, 70752-148 +2Application ANDA214088, ANDA203484, ANDA214291 +1
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 tablet in 1 bottle | 69292-302-01 | Amici Pharma | 15 March 2026 |
| 100 tablet in 1 bottle | 35573-456-02 | Burel Pharmaceuticals | 1 December 2022 |
| 100 tablet in 1 bottle | 68047-721-01 | Larken Laboratories | 4 December 2015 |
| 30 tablet in 1 bottle | 68047-721-30 | Larken Laboratories | 4 December 2015 |
| 100 tablet in 1 bottle | 0603-2540-21 | Par Health | 3 June 1999 |
| 100 tablet in 1 bottle | 70752-148-10 | Quagen Pharmaceuticals | 1 May 2024 |
| 500 tablet in 1 bottle | 70752-148-14 | Quagen Pharmaceuticals | 1 May 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 | 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 and Butalbital 325 mg/50 mg tablet.
Other strengths and forms of Acetaminophen and Butalbital
Clinical summary
Acetaminophen and Butalbital is a fixed-dose combination medicine indicated for the relief of the symptom complex of tension (or muscle contraction) headache. It is available as tablets and capsules for oral use. MedsAcross supplies Acetaminophen and Butalbital 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 and ButalbitalFor 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 and acetaminophen prescribing information (Granules India) · U.S. National Library of Medicine, DailyMed
Need Acetaminophen and Butalbital 325 mg/50 mg tablet 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.