Propranolol Hydrochloride Capsule, Extended Release
NDC Package 70518-3552-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Remedyrepack Inc., this product is identified by NDC 70518-3552 and is authorized under FDA application ANDA212026.

Identification & Billing

NDC Package Code
70518-3552-0
Package Description
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
70518-3552
11-Digit Billing Format
70518355200
RxNorm Crosswalk
  • RxCUI: 856569 - propranolol HCl 80 MG 24HR Extended Release Oral Capsule
  • RxCUI: 856569 - 24 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule
  • RxCUI: 856569 - propranolol hydrochloride 80 MG 24 HR 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 80 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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212026
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-09-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-3552-0 identifies a specific commercial package of 90 capsule, extended release in 1 bottle, plastic of Propranolol Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. 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 Remedyrepack Inc. on October 09, 2022. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518355200. 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 (5-4-1)
70518-3552-0
11-Digit CMS (5-4-2)
70518-3552-00

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