Nexterone
- Product NDC
- 43066-360
- 11-digit product format
- 430660360
- Labeler code
- 43066
- Product ID
- 43066-360_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
- 1.8 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 |
|---|---|
| AMIODARONE HYDROCHLORIDE | 1.8 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 976728SY6Z |
| Rxcui | 849876, 1046406, 1046408, 1046410 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 555d5389-223f-1ce8-3064-82307acfdb0d | Product name | 4 | 20250325 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| b88d5283-0ee6-f0b3-21f1-5522444ef3df | Product name | 3 | 20210204 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 555d5389-223f-1ce8-3064-82307acfdb0d | Product name | 3 | 20171213 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1f5577c0-bdff-03f7-f803-d1d3f05329c2 | Product name | 1 | 20140508 |
| a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43066-360-20 | Nexterone | 200 mL in 1 BAG | INJECTION, SOLUTION | 200 | 23 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046406 | amiodarone HCl 150 MG in 100 ML Injection | PSN | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 849876 | amiodarone HCl 360 MG in 200 ML Injection | PSN | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046408 | Nexterone 150 MG in 100 ML Injection | PSN | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046410 | Nexterone 360 MG in 200 ML Injection | PSN | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046408 | 100 ML amiodarone hydrochloride 1.5 MG/ML Injection [Nexterone] | SBD | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046410 | 200 ML amiodarone hydrochloride 1.8 MG/ML Injection [Nexterone] | SBD | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046406 | 100 ML amiodarone hydrochloride 1.5 MG/ML Injection | SCD | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 849876 | 200 ML amiodarone hydrochloride 1.8 MG/ML Injection | SCD | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046408 | 100 ML Nexterone 1.5 MG/ML Injection | SY | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046410 | 200 ML Nexterone 1.8 MG/ML Injection | SY | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046406 | amiodarone HCl 150 MG per 100 ML Injection | SY | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 849876 | amiodarone HCl 360 MG per 200 ML Injection | SY | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046408 | Nexterone 150 MG per 100 ML Injection | SY | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046410 | Nexterone 360 MG per 200 ML Injection | SY | e9108958-b8d7-4fba-87c3-9a32990de551 | 23 |
| 1046406 | amiodarone HCl 150 MG in 100 ML Injection | PSN | 9d4d66f7-fa14-e832-e053-2a95a90a8b62 | 3 |
| 849876 | amiodarone HCl 360 MG in 200 ML Injection | PSN | 9d4d66f7-fa14-e832-e053-2a95a90a8b62 | 3 |
| 1046406 | 100 ML amiodarone hydrochloride 1.5 MG/ML Injection | SCD | 9d4d66f7-fa14-e832-e053-2a95a90a8b62 | 3 |
| 849876 | 200 ML amiodarone hydrochloride 1.8 MG/ML Injection | SCD | 9d4d66f7-fa14-e832-e053-2a95a90a8b62 | 3 |
| 1046406 | amiodarone HCl 150 MG per 100 ML Injection | SY | 9d4d66f7-fa14-e832-e053-2a95a90a8b62 | 3 |
| 849876 | amiodarone HCl 360 MG per 200 ML Injection | SY | 9d4d66f7-fa14-e832-e053-2a95a90a8b62 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43066-360-20 | 43066036020 | 200 mL in 1 BAG (43066-360-20) | 200 ml | 2010-11-16 | 0000-00-00 | No | No | Current |