Prescription drug · ANDA
Esmolol Hydrochloride (esmolol hydrochloride in sodium chloride) NDC 70121-1717
Esmolol hydrochloride 20 mg/mL · Injection · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1717-3 | 70121171703 | 12 POUCH in 1 CARTON (70121-1717-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Jan 1, 2024 | |
| 70121-1717-7 | 70121171707 | 10 POUCH in 1 CARTON (70121-1717-7) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Dec 16, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216603
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 70121-1717_9fb24e34-22d9-43e6-b611-39e17092e76fSPL ID 9fb24e34-22d9-43e6-b611-39e17092e76fSPL set ID 4cfdfa50-579b-43e7-bc0a-e831d3099bfdRxCUI 979432, 1736541UNII V05260LC8DUPC 0370121171638, 0370121171676, 0370121171775, 0370121171614
- 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
N470121171703followed by a unit qualifier and the quantityPackage 70121-1717-03. 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 in sodium chloride 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 non-compensatory sinus tachycardia. ( 1.1 ) Control of perioperative tachycardia and hypertension. ( 1.2 ) 1.1 Supraventricular Tachycardia or Non-compensatory Sinus Tachycardia Esmolol hydrochloride in sodium chloride 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 ventric…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216603
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 10 mg/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1716 |