Amiodarone hydrochloride
- Product NDC
- 0615-8213
- 11-digit product format
- 006158213
- Labeler code
- 0615
- Product ID
- 0615-8213_59f3629d-c939-4459-8d93-a7b71b6ebd37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA079029
- Marketing category
- ANDA
- Marketing start
- 2009-08-10
- Marketing end
- 2020-07-31
- 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