AMIODARONE HYDROCHLORIDE
- Product NDC
- 51662-1205
- 11-digit product format
- 516621205
- Labeler code
- 51662
- Product ID
- 51662-1205_11ff1d81-1f5f-7624-e063-6294a90ad38e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMIODARONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA077234
- Marketing category
- ANDA
- Marketing start
- 2018-09-19
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1205-1 | AMIODARONE HYDROCHLORIDE | 3 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 3 | | 7 |
| 51662-1205-2 | AMIODARONE HYDROCHLORIDE | 1 mL in 1 POUCH | INJECTION, SOLUTION | 1 | | 7 |
| 51662-1205-3 | AMIODARONE HYDROCHLORIDE | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1205 | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240224_7639dfe4-933c-2916-e053-2a91aa0a3fe7.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 |
|---|
| 51662-1205-1 | 51662120501 | 3 mL in 1 VIAL, SINGLE-DOSE (51662-1205-1) | 3 ml | 2018-09-19 | 0000-00-00 | No | No | Current |
| 51662-1205-2 | 51662120502 | 1 mL in 1 POUCH | 1 ml | | | | | Historical |
| 51662-1205-3 | 51662120503 | 25 POUCH in 1 CASE (51662-1205-3) / 1 mL in 1 POUCH (51662-1205-2) | 25 pouch | 2020-06-15 | 0000-00-00 | No | No | Current |