AMIODARONE HYDROCHLORIDE
- Product NDC
- 51662-1358
- 11-digit product format
- 516621358
- Labeler code
- 51662
- Product ID
- 51662-1358_100d6df7-3400-6068-e063-6294a90a74f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMIODARONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA076217
- Marketing category
- ANDA
- Marketing start
- 2019-07-06
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1358-1 | AMIODARONE HYDROCHLORIDE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 51662-1358-1 | AMIODARONE HYDROCHLORIDE | 18 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 18 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1358 | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240130_8d088060-70b5-e796-e053-2995a90a0969.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1358-1 | 51662135801 | 1 VIAL, GLASS in 1 CARTON (51662-1358-1) / 18 mL in 1 VIAL, GLASS | 2019-07-06 | 0000-00-00 | No | No | Current |