Amiodarone Hydrochloride
- Product NDC
- 55154-8185
- 11-digit product format
- 551548185
- Labeler code
- 55154
- Product ID
- 55154-8185_b0c44872-a74d-4b1f-bd2b-71009f866985
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA204742
- Marketing category
- ANDA
- Marketing start
- 2019-06-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 55154-8185-0 | Amiodarone Hydrochloride | 10 in 1 BAG | TABLET | 10 | | 8 |
| 55154-8185-0 | Amiodarone Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-8185 | AMIODARONE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240608_0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b.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 |
|---|
| 55154-8185-0 | 55154818500 | 10 BLISTER PACK in 1 BAG (55154-8185-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2019-06-15 | 0000-00-00 | No | No | Current |