NDC codes

FDA NDC Directory
Product NDC (as listed)0404-9858Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-9858Add 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 NDC11-digit (billing)PackageCopy
0404-9858-1000404985810004049858101 VIAL, SINGLE-DOSE in 1 BAG (0404-9858-10) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 10, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/10mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Henry Schein, Inc.NDC labeler code 0404
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205520
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 0404-9858_8130e9c3-a1f5-4853-9a39-aa54181f1966SPL ID 8130e9c3-a1f5-4853-9a39-aa54181f1966SPL set ID 519cc19c-e2b6-4984-bfad-45276d4cf0e6RxCUI 1736546UNII V05260LC8D
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

N400404985810 followed by a unit qualifier and the quantity

Package 00404-9858-10. 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)

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 desirable. Esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride injection is intended for short-term use. 1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension Esmolol hydrochloride injecti…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0404-9858

What is NDC 0404-9858?
0404-9858 is the product NDC for Esmolol Hydrochloride, Esmolol hydrochloride 100 mg/10mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Esmolol Hydrochloride.
What is the active ingredient?
Esmolol hydrochloride.
Who is the labeler?
Henry Schein, Inc., NDC labeler code 0404. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Esmolol Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Esmolol HydrochlorideEsmolol hydrochloride 100 mg/10mLInjection, SolutionIntravenousREMEDYREPACK INC.70518-441070518-4410-00
Esmolol HydrochlorideEsmolol hydrochloride 10 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-978500404-9785-10
Esmolol Hydrochlorideesmolol hydrochloride in sodium chlorideEsmolol hydrochloride 10 mg/mLInjectionIntravenousAmneal Pharmaceuticals LLC70121-171670121-1716-0370121-1716-07
Esmolol Hydrochlorideesmolol hydrochloride in sodium chlorideEsmolol hydrochloride 20 mg/mLInjectionIntravenousAmneal Pharmaceuticals LLC70121-171770121-1717-0370121-1717-07
Esmolol Hydrochlorideesmolol hydrochloride in sodium chlorideEsmolol hydrochloride 10 mg/mLInjectionIntravenousWG Critical Care, LLC44567-45044567-0450-10
Esmolol Hydrochlorideesmolol hydrochloride in sodium chlorideEsmolol hydrochloride 20 mg/mLInjectionIntravenousWG Critical Care, LLC44567-45144567-0451-10
esmolol hydrochlorideesmolol hydrochloride in sodium chlorideEsmolol hydrochloride 10 mg/mLInjectionIntravenousEugia US LLC55150-42055150-0420-10
esmolol hydrochlorideesmolol hydrochloride in sodium chlorideEsmolol hydrochloride 20 mg/mLInjectionIntravenousEugia US LLC55150-42155150-0421-10
Esmolol HydrochlorideEsmolol hydrochloride 100 mg/10mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-144451662-1444-0151662-1444-03
Esmolol HydrochlorideEsmolol hydrochloride 10 mg/mLInjectionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-142751662-1427-01

All 24 Esmolol Hydrochloride NDCs

Other NDCs under ANDA 205520

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

FDA NDC Directory listings under ANDA 205520
ProductStrengthForm · routeLabelerProduct NDC
Esmolol HydrochlorideEsmolol hydrochloride 100 mg/10mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1444
Esmolol HydrochlorideEsmolol hydrochloride 100 mg/10mLInjection, SolutionIntravenousEugia US LLC55150-194
Esmolol HydrochlorideEsmolol hydrochloride 100 mg/10mLInjection, SolutionIntravenousREMEDYREPACK INC.70518-4410
Esmolol HydrochlorideEsmolol hydrochloride 100 mg/10mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC71872-7049
Esmolol HydrochlorideEsmolol hydrochloride 100 mg/10mLInjection, SolutionIntravenousProPharma Distribution84549-194

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