NDC Package 0404-9999-01 Propranolol

Propranolol Hydrochloride Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0404-9999-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 BAG / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Propranolol
Non-Proprietary Name:
Propranolol Hydrochloride
Substance Name:
Propranolol Hydrochloride
Usage Information:
Cardiac ArrhythmiasIntravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia.1. Supraventricular arrhythmiasIntravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including Wolff-Parkinson-White syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia.2. Ventricular tachycardiasWith the exception of those induced by catecholamines or digitalis, propranolol is not the drug of first choice. In critical situations when cardioversion techniques or other drugs are not indicated or are not effective, propranolol may be considered. If, after consideration of the risks involved, propranolol is used, it should be given intravenously in low dosage and very slowly, as the failing heart requires some sympathetic drive for maintenance of myocardial tone (see DOSAGE AND ADMINISTRATION).Some patients may respond with complete reversion to normal sinus rhythm, but reduction in ventricular rate is more likely. Ventricular arrhythmias do not respond to propranolol as predictably as do the supraventricular arrhythmias.Intravenous propranolol is indicated for the treatment of persistent premature ventricular extrasystoles that impair the well-being of the patient and do not respond to conventional measures.3. Tachyarrhythmias of digitalis intoxicationIntravenous propranolol is indicated to control ventricular rate in life-threatening digitalis-induced arrhythmias. Severe bradycardia may occur (see OVERDOSAGE).4. Resistant tachyarrhythmias due to excessive catecholamine action during anesthesiaIntravenous propranolol is indicated to abolish tachyarrhythmias due to excessive catecholamine action during anesthesia when other measures fail. These arrhythmias may arise because of release of endogenous catecholamines or administration of catecholamines. All general inhalation anesthetics produce some degree of myocardial depression. Therefore, when propranolol is used to treat arrhythmias during anesthesia, it should be used with extreme caution, usually with constant monitoring of the ECG and central venous pressure (see WARNINGS).
11-Digit NDC Billing Format:
00404999901
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Henry Schein, Inc.
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Sample Package:
No
FDA Application Number:
ANDA075826
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-15-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Frequently Asked Questions

What is NDC 0404-9999-01?

The NDC Packaged Code 0404-9999-01 is assigned to a package of 1 vial, single-dose in 1 bag / 1 ml in 1 vial, single-dose of Propranolol, a human prescription drug labeled by Henry Schein, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

Is NDC 0404-9999 included in the NDC Directory?

Yes, Propranolol with product code 0404-9999 is active and included in the NDC Directory. The product was first marketed by Henry Schein, Inc. on July 15, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0404-9999-01?

The 11-digit format is 00404999901. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20404-9999-015-4-200404-9999-01