Propranolol Hydrochloride Capsule, Extended Release
NDC Package 42291-522-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Propranolol Hydrochloride capsules is propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride. This formulation utilizes a capsule, extended release delivery system. Marketed by Avkare, this product is identified by NDC 42291-522 and is authorized under FDA application ANDA078703.

Identification & Billing

NDC Package Code
42291-522-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
42291-522
11-Digit Billing Format
42291052201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 856460 - propranolol HCl 120 MG 24HR Extended Release Oral Capsule
  • RxCUI: 856460 - 24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule
  • RxCUI: 856460 - propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 856481 - propranolol HCl 160 MG 24HR Extended Release Oral Capsule
  • RxCUI: 856481 - 24 HR propranolol hydrochloride 160 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Propranolol Hydrochloride
Non-Proprietary Name
Propranolol Hydrochloride
Substance Name
Propranolol Hydrochloride
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PROPRANOLOL HYDROCHLORIDE 60 mg/1
Pharmacologic Class
Usage Information
Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA078703
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-16-2017
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42291-522). Click a package code to view its specific billing and regulatory data.

42291-522-10
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-522-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Propranolol Hydrochloride, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This capsule, extended release is formulated for oral use and contains propranolol hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avkare on May 16, 2017. The current certification is valid through December 31, 2027.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291052201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42291-522-01
11-Digit CMS (5-4-2)
42291-0522-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.