Amiodarone Hydrochloride
- Product NDC
- 51862-241
- 11-digit product format
- 518620241
- Labeler code
- 51862
- Product ID
- 51862-241_d1f528b3-67b2-49b5-8f63-3933615a257f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA075389
- Marketing category
- ANDA
- Marketing start
- 2018-04-16
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-241 | AMIODARONE HYDROCHLORIDE TABLET [MAYNE PHARMA COMMERCIAL LLC] | 11 | Legacy NDC | 20241024_77ed916e-13bf-4249-bf45-5ae5d68a84fc.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-241-05 | 51862024105 | 500 TABLET in 1 BOTTLE, PLASTIC (51862-241-05) | 500 tablet | 2018-04-16 | 0000-00-00 | No | No | Current |
| 51862-241-60 | 51862024160 | 60 TABLET in 1 BOTTLE, PLASTIC (51862-241-60) | 60 tablet | 2018-04-16 | 0000-00-00 | No | No | Current |
| 51862-241-90 | 51862024190 | 90 TABLET in 1 BOTTLE, PLASTIC (51862-241-90) | 90 tablet | 2018-04-16 | 0000-00-00 | No | No | Current |