Amiodarone Hydrochloride
- Product NDC
- 0904-7576
- 11-digit product format
- 009047576
- Labeler code
- 0904
- Product ID
- 0904-7576_b8bf4aa2-abea-403d-a6d9-395caf5f87f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078578
- Marketing category
- ANDA
- Marketing start
- 2026-05-12
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 200 mg/1
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 833528 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7576-61 | Amiodarone Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 0904-7576-61 | Amiodarone Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 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 |
|---|
| 0904-7576-61 | 00904757661 | 100 BLISTER PACK in 1 CARTON (0904-7576-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2026-05-12 | No | No | Historical |