amiodarone hydrochloride
- Product NDC
- 68382-298
- 11-digit product format
- 683820298
- Labeler code
- 68382
- Product ID
- 68382-298_b3f11ad6-9f3b-4054-9c51-3d2614c1002e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA079029
- Marketing category
- ANDA
- Marketing start
- 2023-02-09
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-298-06 | 68382029806 | 30 TABLET in 1 BOTTLE (68382-298-06) | 30 tablet | 2023-02-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| amiodarone hydrochloride | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2023-03-16 | HUMAN PRESCRIPTION DRUG LABEL | 19 |