Amiodarone Hydrochloride
- Product NDC
- 65219-645
- 11-digit product format
- 652190645
- Labeler code
- 65219
- Product ID
- 65219-645_9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMIODARONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA075761
- Marketing category
- ANDA
- Marketing start
- 2025-05-05
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 976728SY6Z | AMIODARONE HYDROCHLORIDE | 19774-82-4 | AMIODARONE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-645-09 | 65219064509 | 10 VIAL, SINGLE-DOSE in 1 TRAY (65219-645-09) / 9 mL in 1 VIAL, SINGLE-DOSE (65219-645-01) | 2025-05-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amiodarone Hydrochloride | Fresenius Kabi USA, LLC | 2025-03-06 | HUMAN PRESCRIPTION DRUG LABEL | 1 |