NDC 0281-0326 Nitro-bid

Nitroglycerin Ointment Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0281-0326
Proprietary Name:
Nitro-bid
Non-Proprietary Name: [1]
Nitroglycerin
Substance Name: [2]
Nitroglycerin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Savage Laboratories A Division Of Fougera Pharmaceuticals Inc.
    Labeler Code:
    0281
    FDA Application Number: [6]
    ANDA087355
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-15-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0281-0326-08

    Package Description: 48 PACKET in 1 BOX / 1 g in 1 PACKET

    NDC Code 0281-0326-30

    Package Description: 30 g in 1 TUBE

    Price per Unit: $1.09005 per GM

    NDC Code 0281-0326-60

    Package Description: 60 g in 1 TUBE

    Price per Unit: $1.09374 per GM

    Product Details

    What is NDC 0281-0326?

    The NDC code 0281-0326 is assigned by the FDA to the product Nitro-bid which is a human prescription drug product labeled by Savage Laboratories A Division Of Fougera Pharmaceuticals Inc.. The generic name of Nitro-bid is nitroglycerin. The product's dosage form is ointment and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 0281-0326-08 48 packet in 1 box / 1 g in 1 packet, 0281-0326-30 30 g in 1 tube , 0281-0326-60 60 g in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Nitro-bid?

    Nitroglycerin ointment is used to prevent chest pain (angina) in people with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. It is also not intended to be used just before physical activities (such as exercise, sexual activity) to prevent chest pain. Other medications may be needed in these situations. Consult your doctor for more details.

    What are Nitro-bid Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • NITROGLYCERIN 20 mg/g - A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.

    Which are Nitro-bid UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Nitro-bid Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Nitro-bid?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Nitro-bid?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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    Patient Education

    Nitroglycerin Topical


    Nitroglycerin ointment (Nitro-Bid) is used to prevent episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Nitroglycerin ointment can only be used to prevent attacks of angina; it cannot be used to treat an attack of angina once it has begun. Nitroglycerin ointment (Rectiv) is used in adults to treat pain from anal fissures (a split or tear in the tissue near the rectal area). Nitroglycerin is in a class of medications called vasodilators. Nitroglycerin ointment prevents angina by relaxing the blood vessels so that the heart does not need to work as hard and therefore does not need as much oxygen. Nitroglycerin ointment treats anal fissure pain by relaxing the blood vessels, which reduces the pressure in the anal tissues.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".