Amiodarone Hydrochloride
- Product NDC
- 52584-153
- 11-digit product format
- 525840153
- Labeler code
- 52584
- Product ID
- 52584-153_c67192a4-8e80-4589-89ea-92d54ef07942
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- General Injectables & Vaccines, Inc
- Application
- ANDA076217
- Marketing category
- ANDA
- Marketing start
- 2021-03-24
- Marketing end
- 2023-11-30
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein 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 |
|---|
| 52584-153-03 | 52584015303 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-153-03) > 3 mL in 1 VIAL, SINGLE-DOSE | 2021-03-24 | 0000-00-00 | No | No | Current |