Amiodarone hydrochloride
- Product NDC
- 65841-840
- 11-digit product format
- 658410840
- Labeler code
- 65841
- Product ID
- 65841-840_aabb5533-5d41-49a3-b8b6-14627af57311
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA079029
- Marketing category
- ANDA
- Marketing start
- 2023-02-09
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 100 mg/1
- 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
openFDA Listing Details
- Product ID
- 65841-840_aabb5533-5d41-49a3-b8b6-14627af57311
- SPL ID
- aabb5533-5d41-49a3-b8b6-14627af57311
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Amiodarone hydrochloride
- Generic name
- Amiodarone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2023-02-09
- Marketing category
- ANDA
- Application number
- ANDA079029
- 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]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 100 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 833528, 834348, 835956 |
| Spl Set Id | 3e8db251-e3c5-4fba-be9a-6044a92f0beb |
| Manufacturer Name | Zydus Lifesciences Limited |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 65841-840-06 | 30 TABLET in 1 BOTTLE (65841-840-06) | 2023-02-09 | No |
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 |
|---|
| 65841-840-06 | 65841084006 | 30 TABLET in 1 BOTTLE (65841-840-06) | 30 tablet | 2023-02-09 | No | No | Historical |