Prescription drug · ANDA
Esmolol Hydrochloride NDC 0404-9785
Esmolol hydrochloride 10 mg/mL · Injection, Solution · Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9785-10 | 00404978510 | 1 VIAL in 1 BAG (0404-9785-10) / 10 mL in 1 VIALMarketed from Jun 10, 2025 |
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)
- Esmolol Hydrochloride
- Generic name (nonproprietary)
- esmolol hydrochloride
- Active ingredients
- Esmolol hydrochloride — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076474
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0404-9785_20a0bd84-7968-459c-8218-2b2c98beb7d0SPL ID 20a0bd84-7968-459c-8218-2b2c98beb7d0SPL set ID 9c1e3a64-0ef0-4071-ad6f-63ff8789b198RxCUI 1736546UNII 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
N400404978510followed by a unit qualifier and the quantityPackage 00404-9785-10. 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 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. Esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride injection is intended for short-term use. 1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension Esmolol hydrochloride injecti…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076474
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 | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-182 |
| Esmolol Hydrochloride | Esmolol hydrochloride 10 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1322 |