Amiodarone Hydrochloride
- Product NDC
- 71335-1297
- 11-digit product format
- 713351297
- Labeler code
- 71335
- Product ID
- 71335-1297_21812176-0b2b-418f-8286-9ad756f59219
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204742
- Marketing category
- ANDA
- Marketing start
- 2016-06-03
- Marketing end
- 0000-00-00
- 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 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1297-1 | 71335129701 | 200 TABLET in 1 BOTTLE (71335-1297-1) | 200 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1297-2 | 71335129702 | 30 TABLET in 1 BOTTLE (71335-1297-2) | 30 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1297-3 | 71335129703 | 60 TABLET in 1 BOTTLE (71335-1297-3) | 60 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1297-4 | 71335129704 | 90 TABLET in 1 BOTTLE (71335-1297-4) | 90 tablet | 2019-08-09 | 0000-00-00 | No | No | Current |
| 71335-1297-5 | 71335129705 | 10 TABLET in 1 BOTTLE (71335-1297-5) | 10 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |