Amiodarone Hydrochloride
- Product NDC
- 60505-2658
- 11-digit product format
- 605052658
- Labeler code
- 60505
- Product ID
- 60505-2658_98746026-fdf2-bdf0-c17d-63297c85020c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- APOTEX Corp
- Application
- ANDA078578
- Marketing category
- ANDA
- Marketing start
- 2008-11-06
- Marketing end
- 0000-00-00
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 200 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record