Propranolol Hydrochloride Tablet
NDC Package 68071-3576-1

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

Package Information

Propranolol Hydrochloride tablets is hypertensionPropranolol hydrochloride tablets, USP are indicated in the management of hypertension. This formulation utilizes a tablet delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-3576 and is authorized under FDA application ANDA070177.

Identification & Billing

NDC Package Code
68071-3576-1
Package Description
120 TABLET in 1 BOTTLE, PLASTIC
Product Code
68071-3576
11-Digit Billing Format
68071357601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Propranolol Hydrochloride
Non-Proprietary Name
Propranolol Hydrochloride
Substance Name
Propranolol Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PROPRANOLOL HYDROCHLORIDE 40 mg/1
Pharmacologic Class
Usage Information
HypertensionPropranolol hydrochloride tablets, USP are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies.Angina Pectoris Due to Coronary AtherosclerosisPropranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.Atrial FibrillationPropranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.Myocardial InfarctionPropranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.MigrainePropranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.Essential TremorPropranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism.Hypertrophic Subaortic StenosisPropranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.PheochromocytomaPropranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA070177
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-13-1986
Listing Expiration
12-31-2026
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 68071-3576-1 identifies a specific commercial package of 120 tablet in 1 bottle, plastic of Propranolol Hydrochloride, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This tablet 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 Nucare Pharmaceuticals,inc. on May 13, 1986. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071357601. 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)
68071-3576-1
11-Digit CMS (5-4-2)
68071-3576-01

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