Prescription drug · ANDA
Esmolol Hydrochloride NDC 84549-194
Esmolol hydrochloride 100 mg/10mL · Injection, Solution · Intravenous · ProPharma Distribution
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84549-194-10 | 8454901941084549019410 | 10 mL in 1 VIAL, SINGLE-DOSE (84549-194-10)Marketed from Aug 27, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 100 mg/10mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ProPharma DistributionNDC labeler code 84549
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205520
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 84549-194_463cc756-d1d0-9ffe-e063-6394a90ab342SPL ID 463cc756-d1d0-9ffe-e063-6394a90ab342SPL set ID 3853a26d-782d-f4e7-e063-6294a90a6e47RxCUI 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
N484549019410followed by a unit qualifier and the quantityPackage 84549-0194-10. 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)
Esmolol hydrochloride injection is a beta adrenergic blocker indicated for the short-term treatment of: Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia (1.1) Control of perioperative tachycardia and hypertension (1.2) 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 desirab…
Excerpt only. Read the full label for complete information.
About NDC 84549-194
- What is NDC 84549-194?
- 84549-194 is the product NDC for Esmolol Hydrochloride, Esmolol hydrochloride 100 mg/10mL injection, solution, listed with the FDA by ProPharma Distribution. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Esmolol Hydrochloride.
- What is the active ingredient?
- Esmolol hydrochloride.
- Who is the labeler?
- ProPharma Distribution, NDC labeler code 84549. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Esmolol Hydrochloride?
- 23 other product NDCs are listed under this name. See all Esmolol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Esmolol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Esmolol Hydrochloride | Esmolol hydrochloride 100 mg/10mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4410 | 70518-4410-00 |
| Esmolol Hydrochloride | Esmolol hydrochloride 10 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9785 | 00404-9785-10 |
| Esmolol Hydrochlorideesmolol hydrochloride in sodium chloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1716 | 70121-1716-0370121-1716-07 |
| Esmolol Hydrochlorideesmolol hydrochloride in sodium chloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1717 | 70121-1717-0370121-1717-07 |
| Esmolol Hydrochlorideesmolol hydrochloride in sodium chloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | WG Critical Care, LLC | 44567-450 | 44567-0450-10 |
| Esmolol Hydrochlorideesmolol hydrochloride in sodium chloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | WG Critical Care, LLC | 44567-451 | 44567-0451-10 |
| esmolol hydrochlorideesmolol hydrochloride in sodium chloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | Eugia US LLC | 55150-420 | 55150-0420-10 |
| esmolol hydrochlorideesmolol hydrochloride in sodium chloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | Eugia US LLC | 55150-421 | 55150-0421-10 |
| Esmolol Hydrochloride | Esmolol hydrochloride 100 mg/10mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9858 | 00404-9858-10 |
| Esmolol Hydrochloride | Esmolol hydrochloride 100 mg/10mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1444 | 51662-1444-0151662-1444-03 |
Other NDCs under ANDA 205520
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 100 mg/10mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9858 |
| Esmolol Hydrochloride | Esmolol hydrochloride 100 mg/10mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1444 |
| Esmolol Hydrochloride | Esmolol hydrochloride 100 mg/10mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-194 |
| Esmolol Hydrochloride | Esmolol hydrochloride 100 mg/10mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4410 |
| Esmolol Hydrochloride | Esmolol hydrochloride 100 mg/10mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7049 |