Amiodarone Hydrochloride
- Product NDC
- 50090-5062
- 11-digit product format
- 500905062
- Labeler code
- 50090
- Product ID
- 50090-5062_2aaef59b-6113-4764-8120-0ec936a7a5f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA075389
- Marketing category
- ANDA
- Marketing start
- 2018-08-01
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5062 | AMIODARONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC | 20230208_fd556b8d-4b71-4d33-968a-399b8ec8e6ce.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-5062-1 | 50090506201 | 30 TABLET in 1 BOTTLE (50090-5062-1) | 30 tablet | 2020-05-27 | 0000-00-00 | No | No | Current |
| 50090-5062-2 | 50090506202 | 90 TABLET in 1 BOTTLE (50090-5062-2) | 90 tablet | 2020-05-27 | 0000-00-00 | No | No | Current |