Amiodarone Hydrochloride
- Product NDC
- 0615-8258
- 11-digit product format
- 006158258
- Labeler code
- 0615
- Product ID
- 0615-8258_faf8768b-1bab-4a7d-87c2-b13ee31b1853
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA204742
- Marketing category
- ANDA
- Marketing start
- 2016-06-03
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 833528 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8258-05 | Amiodarone Hydrochloride | 15 in 1 BLISTER PACK | TABLET | 15 | | 4 |
| 0615-8258-39 | Amiodarone Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8258 | AMIODARONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240815_d42293e9-07fa-41b4-a08b-2e388f5b1e13.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8258-05 | 00615825805 | 15 TABLET in 1 BLISTER PACK (0615-8258-05) | 15 tablet | 2019-03-05 | 0000-00-00 | No | No | Current |
| 0615-8258-39 | 00615825839 | 30 TABLET in 1 BLISTER PACK (0615-8258-39) | 30 tablet | 2019-03-05 | 0000-00-00 | No | No | Current |