AMIODARONE HYDROCHLORIDE
- Product NDC
- 0404-9772
- 11-digit product format
- 004049772
- Labeler code
- 0404
- Product ID
- 0404-9772_17458257-a90d-43d1-891f-56ebf2fe73b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA077234
- Marketing category
- ANDA
- Marketing start
- 2025-10-29
- 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 |
|---|
| 0404-9772-03 | AMIODARONE HYDROCHLORIDE | 3 mL in 1 VIAL | INJECTION, SOLUTION | 3 | | 1 |
| 0404-9772-03 | AMIODARONE HYDROCHLORIDE | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9772-03 | 00404977203 | 1 VIAL in 1 BAG (0404-9772-03) / 3 mL in 1 VIAL | 1 vial | 2025-10-29 | No | No | Historical |