Amiodarone Hydrochloride
- Product NDC
- 71335-1942
- 11-digit product format
- 713351942
- Labeler code
- 71335
- Product ID
- 71335-1942_5b27ec4d-eebc-445d-a4ab-fced073afaa6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213446
- Marketing category
- ANDA
- Marketing start
- 2020-09-01
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 200 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 833528 |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1942-1 | 71335194201 | 200 TABLET in 1 BOTTLE (71335-1942-1) | 200 tablet | 2021-09-03 | 0000-00-00 | No | No | Current |
| 71335-1942-2 | 71335194202 | 30 TABLET in 1 BOTTLE (71335-1942-2) | 30 tablet | 2021-09-03 | 0000-00-00 | No | No | Current |
| 71335-1942-3 | 71335194203 | 60 TABLET in 1 BOTTLE (71335-1942-3) | 60 tablet | 2021-09-03 | 0000-00-00 | No | No | Current |
| 71335-1942-4 | 71335194204 | 90 TABLET in 1 BOTTLE (71335-1942-4) | 90 tablet | 2021-09-03 | 0000-00-00 | No | No | Current |
| 71335-1942-5 | 71335194205 | 10 TABLET in 1 BOTTLE (71335-1942-5) | 10 tablet | 2021-09-03 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amiodarone Hydrochloride | Bryant Ranch Prepack | 2025-12-30 | HUMAN PRESCRIPTION DRUG LABEL | 104 |