Nexterone
- Product NDC
- 43066-150
- 11-digit product format
- 430660150
- Labeler code
- 43066
- Product ID
- 43066-150_29c4e07e-f55e-4c19-8638-c4b9eb12efcf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Company
- Application
- NDA022325
- Marketing category
- NDA
- Marketing start
- 2010-11-16
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 1.5 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nexterone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 1.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 849876, 1046406, 1046408, 1046410 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43066-150-10 | Nexterone | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMIODARONE HYDROCHLORIDE | ACTIVE INGREDIENT | 976728SY6Z | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
| AMIODARONE | ACTIVE MOIETY | N3RQ532IUT | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
| SULFOBUTYLETHER .BETA.-CYCLODEXTRIN | INACTIVE INGREDIENT | 2PP9364507 | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43066-150 | NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] | 21 | Current NDC, Legacy NDC, 1 package rows | 20250309_e9108958-b8d7-4fba-87c3-9a32990de551.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 |
|---|
| 43066-150-10 | 43066015010 | 100 mL in 1 BAG (43066-150-10) | 100 ml | 2010-11-16 | 0000-00-00 | No | No | Current |