AMIODARONE HYDROCHLORIDE
- Product NDC
- 52584-063
- 11-digit product format
- 525840063
- Labeler code
- 52584
- Product ID
- 52584-063_f7e94f56-0b45-4c16-9439-e3f6eb7dfd32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMIODARONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA077234
- Marketing category
- ANDA
- Marketing start
- 2018-06-11
- Marketing end
- 2022-04-30
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 50 mg/mL
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-063-01 | 52584006301 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-063-01) > 3 mL in 1 VIAL, SINGLE-DOSE | 2018-06-11 | 0000-00-00 | No | No | Current |