NDC 64117-543 Headache

Nitroglycerin

NDC Product Code 64117-543

NDC CODE: 64117-543

Proprietary Name: Headache 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: Nitroglycerin 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 Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin 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.

NDC Code Structure

NDC 64117-543-01

Package Description: 1.875 mL in 1 BOTTLE, GLASS

NDC 64117-543-02

Package Description: 7.5 mL in 1 BOTTLE, GLASS

NDC Product Information

Headache with NDC 64117-543 is a a human over the counter drug product labeled by Natural Health Supply. The generic name of Headache is nitroglycerin. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Natural Health Supply

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

Product Type: Human Otc 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.

Headache Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NITROGLYCERIN 30 [hp_C]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • LACTOSE (UNII: J2B2A4N98G)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Natural Health Supply
Labeler Code: 64117
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 06-04-1998 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: 12-31-2021 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 - NO 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".

* Please review the disclaimer below.

Headache Product Label Images

Headache Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications

Indications: To be used for acute self-limiting conditions according to standard homeopathic indications

Active Ingredient

GLONOINUM

Directions

Take at onset of symptoms.  Repeat every 2 hours or as needed until relieved.  If condition persists or worsens discontinue use and consult a practitioner.Adults: dissolve 5-10 pellets in 1 oz. of filtered water or take dry by mouth.  Children and infants: 1-5 pellets.

Keep Out Of Reach Of Children

Keep these and all medications out of the reach of children.

Warning

If pregnant or nursing, consult a practitioner before using.

Inactive Ingredients

Inactive Ingredients - Lactose, Sucrose

Purpose

Purpose: Headache

Package Label

Est. No. 1724217Natural Health Supply505-474-9175Homeopathic Medicated PelletsDo not use if clear bottle seal is brokenGLONOINUM 30CHeahacheLot #__________________

* Please review the disclaimer below.