Amiodarone HCl
- Product NDC
- 51862-155
- 11-digit product format
- 518620155
- Labeler code
- 51862
- Product ID
- 51862-155_02f504e6-835e-44c8-828e-9352e78c8e75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA077069
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Marketing end
- 2019-12-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record