Prescription drug · NDA
Brevibloc (esmolol hydrochloride) NDC 0404-9825
Esmolol hydrochloride 10 mg/mL · Injection · Intravenous · Henry Schein, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9825-10 | 00404982510 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9825-10) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 9, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Brevibloc
- Generic name (nonproprietary)
- esmolol hydrochloride
- Active ingredients
- Esmolol hydrochloride — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Henry Schein, Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019386
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0404-9825_e898a56b-15fa-4ef7-be89-59d27637afe1SPL ID e898a56b-15fa-4ef7-be89-59d27637afe1SPL set ID 38a8b23a-fca8-45f4-a09a-9c8b21f522cdRxCUI 1736546, 1736547UNII V05260LC8D
- Pharmacologic class
- beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400404982510followed by a unit qualifier and the quantityPackage 00404-9825-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. BREVIBLOC injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. BREVIBLOC injection is intended for short-term use. 1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension BREVIBLOC (Esmolol Hydrochloride) injecti…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019386
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Esmolol Hydrochloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1427 |
| Esmolol Hydrochloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7136 |
| Breviblocesmolol hydrochloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 10019-666 |
| Breviblocesmolol hydrochloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 10019-668 |
| Breviblocesmolol hydrochloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 10019-670 |
| Breviblocesmolol hydrochloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 10019-672 |
| Breviblocesmolol hydrochloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 10019-055 |
| Breviblocesmolol hydrochloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 10019-075 |
| Breviblocesmolol hydrochloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 10019-115 |
| Esmolol Hydrochloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 10019-120 |