NDC 76385-133-01 Nadolol

Nadolol

NDC Package Code 76385-133-01

The NDC Code 76385-133-01 is assigned to a package of 100 tablet in 1 bottle of Nadolol, a human prescription drug labeled by Bayshore Pharmaceuticals Llc. The product's dosage form is tablet and is administered via oral form.

Field Name Field Value
NDC Code 76385-133-01
Package Description 100 TABLET in 1 BOTTLE
Proprietary Name Nadolol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Nadolol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses Nadolol is used alone or with other medications to treat high blood pressure (hypertension) and to prevent chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. In the management of chest pain, nadolol may also help to reduce the frequency of chest pain episodes and improve your ability to exercise. Nadolol belongs to a class of medications called beta blockers. It works by blocking the action of certain natural substances such as adrenaline (epinephrine) on the heart and blood vessels. This results in a lowering of heart rate, blood pressure, and strain on the heart.
11-Digit NDC Billing Format 76385013301 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Bayshore Pharmaceuticals Llc
Dosage Form Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • NADOLOL 20 mg/1
Pharmacological Class(es)
  • Adrenergic beta-Antagonists - [MoA] (Mechanism of Action)
  • beta-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANDA210955 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 07-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

NDC Code Structure

  • 76385 - Bayshore Pharmaceuticals Llc
    • 76385-133 - Nadolol
      • 76385-133-01 - 100 TABLET in 1 BOTTLE

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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Other Product Packages

The following packages are also available for Nadolol with product NDC 76385-133.

NDC Package CodePackage Description
76385-133-101000 TABLET in 1 BOTTLE

* Please review the disclaimer below.