Amiodarone Hydrochloride
- Product NDC
- 70518-1939
- 11-digit product format
- 705181939
- Labeler code
- 70518
- Product ID
- 70518-1939_4b421f7b-f793-59d4-e063-6294a90a13dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204742
- Marketing category
- ANDA
- Marketing start
- 2019-03-06
- 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 |
|---|
| 70518-1939-0 | Amiodarone Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 11 |
| 70518-1939-1 | Amiodarone Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 11 |
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 |
|---|
| 70518-1939-0 | 70518193900 | 30 TABLET in 1 BLISTER PACK (70518-1939-0) | 30 tablet | 2019-03-06 | 0000-00-00 | No | No | Current |
| 70518-1939-1 | 70518193901 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1939-1) | 90 tablet | 2021-02-23 | 0000-00-00 | No | No | Current |