Amiodarone Hydrochloride
- Product NDC
- 16714-845
- 11-digit product format
- 167140845
- Labeler code
- 16714
- Product ID
- 16714-845_a8080caa-eaa9-4cff-a8ef-15c945bf60e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA075389
- Marketing category
- ANDA
- Marketing start
- 2018-08-01
- Marketing end
- 0000-00-00
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 16714-845-01 | 16714084501 | 30 TABLET in 1 BOTTLE, PLASTIC (16714-845-01) | 30 tablet | 2018-08-01 | 0000-00-00 | No | No | Current |