Medicine
Acetaminophen and Butalbital 300 mg/50 mg capsule
Acetaminophen and Butalbital 300 mg/50 mg capsule is a generic prescription medicine for oral use, made by 2 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°C to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Acetaminophen and Butalbital
- Brand
- Sold under the generic name
- Strength
- 300 mg/50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules
- Manufacturers
- Granules IndiaIndiaDr. Reddy's LaboratoriesIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68° to 77°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
- 20 January 2020
- Identifiers
- RxCUI 1995136DailyMed set ID 2091c292-b77b-4ce6-8bba-436c74eee3d7, 42d808d6-d8d4-22f5-ac2f-0f0d1d71686aNDC 70010-054, 75907-008Application ANDA213115, ANDA207313
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 | 75907-008-01 | Dr. Reddy's LaboratoriesIndia | 1 September 2024 |
| 100 capsule in 1 bottle | 70010-054-01 | Granules IndiaIndia | 20 January 2020 |
| 500 capsule in 1 bottle | 70010-054-05 | Granules IndiaIndia | 20 January 2020 |
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 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 300 mg/50 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.