Prescription drug · ANDA
esmolol hydrochloride in sodium chloride NDC 67457-657
Esmolol hydrochloride 10 mg/mL · Injection · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-657-25 | 6745706572567457065725 | 1 BAG in 1 POUCH (67457-657-25) / 250 mL in 1 BAGMarketed from Sep 4, 2018 |
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 in sodium chloride
- Generic name (nonproprietary)
- esmolol hydrochloride in sodium chloride
- Active ingredients
- Esmolol hydrochloride — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206608
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 67457-657_4fdea9d3-714d-4d54-9c23-bde0edd85b59SPL ID 4fdea9d3-714d-4d54-9c23-bde0edd85b59SPL set ID 01ad7942-99c3-40ee-9cfb-272fb6c44e2bRxCUI 979432, 1736541UNII V05260LC8DUPC 0367457658100
- 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
N467457065725followed by a unit qualifier and the quantityPackage 67457-0657-25. 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 ventric…
Excerpt only. Read the full label for complete information.
About NDC 67457-657
- What is NDC 67457-657?
- 67457-657 is the product NDC for esmolol hydrochloride in sodium chloride, Esmolol hydrochloride 10 mg/mL injection, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- esmolol hydrochloride in sodium chloride.
- What is the active ingredient?
- Esmolol hydrochloride.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. 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 in sodium chloride?
- 1 other product NDC are listed under this name. See all esmolol hydrochloride in sodium chloride 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 in sodium chloride 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 in sodium chloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | Mylan Institutional LLC | 67457-658 | 67457-0658-10 |
Other NDCs under ANDA 206608
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 in sodium chloride | Esmolol hydrochloride 20 mg/mL | InjectionIntravenous | Mylan Institutional LLC | 67457-658 |