AMIODARONE HCI
- Product NDC
- 51662-1363
- 11-digit product format
- 516621363
- Labeler code
- 51662
- Product ID
- 51662-1363_ef7bd6e6-d62f-7e93-e053-2a95a90aef83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMIODARONE HCI
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA075761
- Marketing category
- ANDA
- Marketing start
- 2019-12-08
- 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 3A4 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 HCI
- 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 |
|---|
| 51662-1363-1 | AMIODARONE HCI | 3 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1363 | AMIODARONE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, Legacy NDC, 1 package rows | 20221211_993b2557-6774-bb7a-e053-2995a90a0503.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 |
|---|
| 51662-1363-1 | 51662136301 | 3 mL in 1 VIAL, SINGLE-DOSE (51662-1363-1) | 3 ml | 2019-12-08 | 0000-00-00 | No | No | Current |