Drug
Who makes amiodarone hydrochloride?
32 companies list amiodarone hydrochloride as a human prescription drug, including under the names Nexterone, Pacerone. Forms: injection, solution; tablet. Routes: intravenous, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing amiodarone hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Medical Purchasing Solutions, LLCUnited States | injection, solution | ANDAANDA075761, ANDA076217, ANDA077234 | 5 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | ANDAANDA075424, ANDA076362 | 4 | 13 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA075135, ANDA075424, ANDA078578 | 4 | 1 |
| RemedyRepack, IncUnited States | injection, solution; tablet | ANDAANDA077234, ANDA078578, ANDA204742 | 4 | 1 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA079029 | 3 | 12 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA075761 | 3 | 6 |
| Zhejiang Poly Pharm Co LtdChina | injection, solution | ANDAANDA218253 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA079029 | 3 | 1 |
| Advagen Pharma Limited | tablet | ANDAANDA078578 | 3 | 0 |
| AuroMedics Pharma LLC | injection, solution | ANDAANDA204550 | 3 | 0 |
| Chartwell RX, LLC. | tablet | ANDAANDA077069 | 3 | 0 |
| Upsher-Smith Laboratories, Inc. | tablet | ANDAANDA075135 | 3 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA075424, ANDA204742 | 2 | 34 |
| Baxter Healthcare CorporationUnited States | injection, solution | NDANDA022325 | 2 | 16 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA204742, ANDA213446 | 2 | 3 |
| HF Acquisition Co LLCUnited States | injection, solution | ANDAANDA076217, ANDA077234 | 2 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA078578, ANDA204742 | 2 | 1 |
| Dr. Reddy's Labratories Inc. | tablet | ANDAANDA075389 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA075424, ANDA078578 | 2 | 0 |
| Mylan Institutional Inc. | injection, solution | ANDAANDA076217 | 2 | 0 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA204742 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA204742 | 1 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA213446 | 1 | 5 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA077161 | 1 | 4 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution | ANDAANDA077234 | 1 | 4 |
| ProPharma Distribution, LLC.United States | injection, solution | ANDAANDA076217 | 1 | 3 |
| Safecor Health, LLCUnited States | tablet | ANDAANDA079029 | 1 | 3 |
| Henry Schein, Inc.United States | injection, solution | ANDAANDA077234 | 1 | 1 |
| RedPharm DrugUnited States | tablet | ANDAANDA213446 | 1 | 1 |
| Slate Run Pharmaceuticals, LLCUnited States | injection, solution | ANDAANDA218253 | 1 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDAANDA075135 | 1 | 0 |
| AvPAK | tablet | ANDAANDA075389 | 1 | 0 |
Bulk ingredient listings
- CTX Lifesciences Pvt. Ltd.India · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- PMC IsochemFrance · 1 NDC
- Piramal Healthcare (Canada) LimitedIndia · 1 NDC
Orange Book patents
6 unexpired patents list amiodarone hydrochloride as the active ingredient, expiring between Mar 2029 and Feb 2033. Application holder: BAXTER HEALTHCARE CORP.
Enquiry
Common questions
- Who makes amiodarone hydrochloride?
- 32 companies list amiodarone hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Medical Purchasing Solutions, LLC, Sun Pharmaceutical Industries Limited, Bryant Ranch Prepack, RemedyRepack, Inc, Zydus Lifesciences Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Nexterone?
- 31 companies list amiodarone hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies amiodarone hydrochloride active ingredient?
- 5 companies list amiodarone hydrochloride as a bulk ingredient, including CTX Lifesciences Pvt. Ltd., Emcure Pharmaceuticals Limited, Olon USA LLC, PMC Isochem.