Medicine
Pacerone 100 mg tablet
Pacerone 100 mg tablet is a prescription medicine containing Amiodarone for oral use, marketed by Upsher-Smith Laboratories, 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° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Amiodarone
- Brand
- Pacerone
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 blister pack, 100 tablets, 30 tablets and 1 more
- Marketing authorisation holder
- Upsher-Smith Laboratories
- Manufacturers
- Upsher-Smith LaboratoriesBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01BD01 Amiodarone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 November 2010
- Identifiers
- RxCUI 833528, 834346, 834348 +3DailyMed set ID 4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7, dcadce9c-d0a0-4235-8ff8-dd93c09e03b3NDC 0245-0144, 72162-2148Application ANDA075135
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0245-0144-01 | Upsher-Smith Laboratories | 19 January 2011 |
| 100 tablet in 1 bottle | 0245-0144-11 | Upsher-Smith Laboratories | 19 January 2011 |
| 30 tablet in 1 bottle | 0245-0144-30 | Upsher-Smith Laboratories | 19 January 2011 |
| 30 tablet in 1 bottle | 72162-2148-3 | Bryant Ranch Prepack | 7 December 2023 |
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 24 December 1985 | 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 Amiodarone 100 mg tablet.
Other strengths and forms of Amiodarone
Clinical summary
Amiodarone is an antiarrhythmic indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. MedsAcross supplies Amiodarone 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 AmiodaroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nexterone prescribing information (Baxter Healthcare) · U.S. National Library of Medicine, DailyMed
Need Pacerone 100 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.