Prescription drug · ANDA
esmolol hydrochloride (Esmolol hydrochloride in sodium chloride) NDC 55150-420
Esmolol hydrochloride 10 mg/mL · Injection · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-420-10 | 5515004201055150042010 | 10 POUCH in 1 CARTON (55150-420-10) / 1 BAG in 1 POUCH (55150-420-01) / 250 mL in 1 BAGMarketed from Mar 21, 2022 |
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 in sodium chloride
- Active ingredients
- Esmolol hydrochloride — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216244
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 55150-420_5aebd586-47c6-4e19-88e3-ef0ecb1cc875SPL ID 5aebd586-47c6-4e19-88e3-ef0ecb1cc875SPL set ID ac22475d-2d78-469f-9435-b403ac4ee380RxCUI 979432, 1736541, 1736546UNII V05260LC8DUPC 0355750420012, 0355150421015
- 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
N455150042010followed by a unit qualifier and the quantityPackage 55150-0420-10. 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 55150-420
- What is NDC 55150-420?
- 55150-420 is the product NDC for esmolol hydrochloride (esmolol hydrochloride in sodium chloride), Esmolol hydrochloride 10 mg/mL injection, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- esmolol hydrochloride (Esmolol hydrochloride in sodium chloride).
- What is the active ingredient?
- Esmolol hydrochloride.
- Who is the labeler?
- Eugia US LLC, NDC labeler code 55150. 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 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 |
| Esmolol Hydrochloride | Esmolol hydrochloride 10 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1427 | 51662-1427-01 |
Other NDCs under ANDA 216244
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 hydrochlorideesmolol hydrochloride in sodium chloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | Eugia US LLC | 55150-421 |