Esmolol Hydrochloride NDC 63323-661

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-661Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0661Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
63323-661-14	63323066114	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-661-14) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-661-04)Marketed from Jan 13, 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 — 10 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076573
Marketing start: Nov 30, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 63323-661_961c04d5-1f12-4095-a4b9-1842574f7f97SPL ID 961c04d5-1f12-4095-a4b9-1842574f7f97SPL set ID fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2RxCUI 1736546UNII V05260LC8DUPC 0363323661045, 0363323652012
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.

How CPT relates to drug billing

NDC on a medical claim

N463323066114 followed by a unit qualifier and the quantity

Package 63323-0661-14. 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 Nov 14, 2024.

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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076573

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076573
Product	Strength	Form · route	Labeler	Product NDC
Esmolol Hydrochloride	Esmolol hydrochloride 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-652
Esmolol Hydrochloride	Esmolol hydrochloride 10 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1371