NDC 67457-153 – Amiodarone Hydrochloride
Amiodarone Hydrochloride 50 mg/mL · Injection, Solution · Intravenous
Product NDC67457-153
Product details
- Brand name
- Amiodarone Hydrochloride
- Generic name
- Amiodarone hydrochloride
- Labeler
- Mylan Institutional LLC
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Marketing category
- ANDA · ANDA076217
- Marketed since
- October 14, 2002
- Listing expires
- December 31, 2026
- Pharmacologic class
- Antiarrhythmic
Active ingredients
- Amiodarone Hydrochloride 50 mg/mL
Uses, dosage, side effects and warnings for Amiodarone Hydrochloride →
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 67457-153-03 | 10 VIAL, GLASS in 1 CARTON (67457-153-03) / 3 mL in 1 VIAL, GLASS (67457-153-00) | Oct 15, 2002 |
| 67457-153-09 | 10 VIAL, GLASS in 1 CARTON (67457-153-09) / 9 mL in 1 VIAL, GLASS (67457-153-99) | Jan 5, 2004 |
| 67457-153-18 | 1 VIAL, GLASS in 1 CARTON (67457-153-18) / 18 mL in 1 VIAL, GLASS | Nov 14, 2003 |
Recalls mentioning this NDC
- D-1575-2020 Sep 9, 2020 · Class I
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… - D-0005-2015 Oct 15, 2014 · Class II
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.
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