amiodarone hydrochloride
- Product NDC
- 25021-302
- 11-digit product format
- 250210302
- Labeler code
- 25021
- Product ID
- 25021-302_ea8dff05-ad63-45e7-8d37-aa998a0d49b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA077161
- Marketing category
- ANDA
- Marketing start
- 2013-07-15
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 25021-302-66 | 25021030266 | 10 SYRINGE in 1 CARTON (25021-302-66) > 3 mL in 1 SYRINGE | 10 syringe | 2013-07-15 | 0000-00-00 | No | No | Current |