Amiodarone Hydrochloride
- Product NDC
- 70436-232
- 11-digit product format
- 704360232
- Labeler code
- 70436
- Product ID
- 70436-232_31c43944-e7af-8d8d-e063-6394a90a3b45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Slate Run Pharmaceuticals
- Application
- ANDA218253
- Marketing category
- ANDA
- Marketing start
- 2024-10-31
- 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, 1663244, 1663248 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-232-50 | Amiodarone Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 70436-232-50 | Amiodarone Hydrochloride | 18 mL in 1 VIAL | INJECTION, SOLUTION | 18 | | 3 |
| 70436-232-52 | Amiodarone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
| 70436-232-52 | Amiodarone Hydrochloride | 3 mL in 1 VIAL | INJECTION, SOLUTION | 3 | | 3 |
| 70436-232-62 | Amiodarone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
| 70436-232-62 | Amiodarone Hydrochloride | 9 mL in 1 VIAL | INJECTION, SOLUTION | 9 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-232 | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS] | 3 | Current NDC, 6 package rows | 20250406_3a53668c-adda-44c2-a743-e79e467437e3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70436-232-50 | 70436023250 | 1 VIAL in 1 CARTON (70436-232-50) / 18 mL in 1 VIAL | 1 vial | 2024-10-31 | No | No | Historical |
| 70436-232-52 | 70436023252 | 10 VIAL in 1 CARTON (70436-232-52) / 3 mL in 1 VIAL | 10 vial | 2024-10-31 | No | No | Historical |
| 70436-232-62 | 70436023262 | 10 VIAL in 1 CARTON (70436-232-62) / 9 mL in 1 VIAL | 10 vial | 2024-10-31 | No | No | Historical |