Amiodarone Hydrochloride
- Product NDC
- 67457-153
- 11-digit product format
- 674570153
- Labeler code
- 67457
- Product ID
- 67457-153_bd9c578c-322f-41fc-936d-bf9b551a2782
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA076217
- Marketing category
- ANDA
- Marketing start
- 2002-10-14
- 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 3A4 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 |
|---|
| 67457-153-00 | Amiodarone Hydrochloride | 3 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 3 | | 17 |
| 67457-153-03 | Amiodarone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 17 |
| 67457-153-09 | Amiodarone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 17 |
| 67457-153-18 | Amiodarone Hydrochloride | 18 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 18 | | 17 |
| 67457-153-18 | Amiodarone Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 17 |
| 67457-153-99 | Amiodarone Hydrochloride | 9 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 9 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Amiodarone Hydrochloride | ACTIVE INGREDIENT | 976728SY6Z | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 8 | |
| Amiodarone | ACTIVE MOIETY | N3RQ532IUT | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 8 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 8 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 8 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 8 | |
| Amiodarone Hydrochloride | ACTIVE INGREDIENT | 976728SY6Z | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| Amiodarone | ACTIVE MOIETY | N3RQ532IUT | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-153 | AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 17 | Current NDC, Legacy NDC, 6 package rows | 20201120_fcc8658c-761a-443f-8c32-1499d86028ec.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 |
|---|
| 67457-153-00 | 67457015300 | 3 mL in 1 VIAL, GLASS | 3 ml | | | | | Historical |
| 67457-153-03 | 67457015303 | 10 VIAL, GLASS in 1 CARTON (67457-153-03) / 3 mL in 1 VIAL, GLASS (67457-153-00) | | 2002-10-15 | 0000-00-00 | No | No | Current |
| 67457-153-09 | 67457015309 | 10 VIAL, GLASS in 1 CARTON (67457-153-09) / 9 mL in 1 VIAL, GLASS (67457-153-99) | | 2004-01-05 | 0000-00-00 | No | No | Current |
| 67457-153-18 | 67457015318 | 1 VIAL, GLASS in 1 CARTON (67457-153-18) / 18 mL in 1 VIAL, GLASS | | 2003-11-14 | 0000-00-00 | No | No | Current |
| 67457-153-99 | 67457015399 | 9 mL in 1 VIAL, GLASS | 9 ml | | | | | Historical |