Prescription drug · ANDA
esmolol hydrochloride NDC 25021-308
Esmolol hydrochloride 10 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-308-84 | 25021030884 | 10 BAG in 1 CARTON (25021-308-84) / 250 mL in 1 BAGMarketed from Jul 15, 2019 |
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 — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207107
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 25021-308_f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9bSPL ID f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9bSPL set ID f12fb0fd-fa05-49fc-b5e3-a2050b816ef2RxCUI 979432, 1736541UNII V05260LC8DUPC 0325021308844, 0325021309827
- 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
N425021030884followed by a unit qualifier and the quantityPackage 25021-0308-84. 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 noncompensatory sinus tachycardia ( 1.1 ) Control of perioperative tachycardia and hypertension ( 1.2 ) 1.1 Supraventricular Tachycardia or Noncompensatory 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 ventricular…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207107
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 20 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-309 |