NDC 52584-115
Brevibloc
Brevibloc
Brevibloc is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines. The primary component is Esmolol Hydrochloride.
| Product ID | 52584-115_2127d70a-753e-4fc6-bf12-95cba9332113 |
| NDC | 52584-115 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Brevibloc |
| Generic Name | Brevibloc |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2010-07-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019386 |
| Labeler Name | General Injectables & Vaccines |
| Substance Name | ESMOLOL HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/mL |
| Pharm Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 52584-115-39
1 VIAL, SINGLE-DOSE in 1 BAG (52584-115-39) > 10 mL in 1 VIAL, SINGLE-DOSE
| Marketing Start Date | 2016-09-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 52584-115-39 [52584011539]
Brevibloc INJECTION
| Marketing Category | NDA |
| Application Number | NDA019386 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-09-14 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ESMOLOL HYDROCHLORIDE | 10 mg/mL |
OpenFDA Data
| SPL SET ID: | c8d2e135-ec31-4eee-bce2-c85e7858c5e1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Adrenergic beta-Antagonists [MoA]
- beta-Adrenergic Blocker [EPC]
NDC Crossover Matching brand name "Brevibloc" or generic name "Brevibloc"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0404-9825 | Brevibloc | esmolol hydrochloride |
| 10019-055 | Brevibloc | Esmolol Hydrochloride |
| 10019-075 | Brevibloc | Esmolol Hydrochloride |
| 10019-115 | Brevibloc | Esmolol Hydrochloride |
| 10019-666 | BREVIBLOC | esmolol hydrochloride |
| 10019-668 | BREVIBLOC | esmolol hydrochloride |
| 10019-670 | BREVIBLOC | esmolol hydrochloride |
| 10019-672 | BREVIBLOC | BREVIBLOC |
| 52584-115 | Brevibloc | Brevibloc |
Trademark Results [Brevibloc]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BREVIBLOC 73433960 1287620 Live/Registered |
American Hospital Supply Corporation 1983-07-08 |
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