PillAmiodarone Hydrochloride
Brands: Nexterone · Amiodarone Hydrochloride
13 active makers
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US acquisition costNADAC · per unit
Average across 2 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it13 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Mylan Institutional LLC | unknown | 5 | SUPPLYING |
| Medical Purchasing Solutions, LLC | unknown | 5 | SUPPLYING |
| Fresenius Kabi USA, LLC | unknown | 4 | SUPPLYING |
| Zhejiang Poly Pharm. Co., Ltd. | unknown | 3 | SUPPLYING |
| HF Acquisition Co LLC, DBA HealthFirst | unknown | 3 | SUPPLYING |
| AuroMedics Pharma LLC | unknown | 3 | SUPPLYING |
| Slate Run Pharmaceuticals, LLC | unknown | 3 | SUPPLYING |
| Hikma Pharmaceuticals USA Inc. | unknown | 2 | SUPPLYING |
| Baxter Healthcare Corporation | unknown | 2 | SUPPLYING |
| Henry Schein Inc. | unknown | 1 | SUPPLYING |
| Gland Pharma Limited | unknown | 1 | SUPPLYING |
| ProPharma Distribution | unknown | 1 | SUPPLYING |
| REMEDYREPACK INC. | repackager | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Aug 17, 2020RECALLRecall (Class I): Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Si…
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. — Recalling firm: Mylan Institutional LLC — Nationwide
- Nov 11, 2019RECALLRecall (Class III): Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed …
Crystallization: Presence of visible particulate matter. — Recalling firm: AuroMedics Pharma LLC — Distributed Nationwide in the US
- Nov 11, 2019RECALLRecall (Class III): Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by A…
Crystallization: Presence of visible particulate matter. — Recalling firm: AuroMedics Pharma LLC — Distributed Nationwide in the US
- Nov 11, 2019RECALLRecall (Class III): Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by A…
Crystallization: Presence of visible particulate matter. — Recalling firm: AuroMedics Pharma LLC — Distributed Nationwide in the US
- Nov 10, 2017RECALLRecall (Class I): Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporatio…
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged — Recalling firm: Baxter Healthcare Corporation — Nationwide within USA and Puerto Rico
- Sep 12, 2014RECALLRecall (Class II): Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institution…
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers. — Recalling firm: Mckesson — McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.