Amiodarone Hydrochloride
- Product NDC
- 71872-7163
- 11-digit product format
- 718727163
- Labeler code
- 71872
- Product ID
- 71872-7163_fbbf8de0-338f-728d-e053-6294a90a5451
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Medical Purchasing Solutions, LLC
- Application
- ANDA076217
- Marketing category
- ANDA
- Marketing start
- 2002-10-14
- 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 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 | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 1663224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71872-7163-1 | Amiodarone Hydrochloride | 3 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 3 | | 2 |
| 71872-7163-1 | Amiodarone Hydrochloride | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71872-7163 | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230516_8969aad3-0219-e67f-e053-2995a90aac5a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71872-7163-1 | 71872716301 | 1 VIAL, GLASS in 1 BAG (71872-7163-1) / 3 mL in 1 VIAL, GLASS | 2019-05-01 | 0000-00-00 | No | No | Current |