Amiodarone Hydrochloride
- Product NDC
- 65219-643
- 11-digit product format
- 652190643
- Labeler code
- 65219
- Product ID
- 65219-643_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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 1663224, 1663244 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-643-01 | Amiodarone Hydrochloride | 3 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 3 | | 1 |
| 65219-643-03 | Amiodarone Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-643 | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20250506_9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-643-01 | 65219064301 | 3 mL in 1 VIAL, SINGLE-DOSE | 3 ml | | | | Historical |
| 65219-643-03 | 65219064303 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-643-03) / 3 mL in 1 VIAL, SINGLE-DOSE (65219-643-01) | | 2025-05-05 | No | No | Current |