NDC 76233-072 Ganciclovir

Ganciclovir Sodium

NDC Product Code 76233-072

NDC CODE: 76233-072

Proprietary Name: Ganciclovir 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: Ganciclovir Sodium 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.

  • Ganciclovir is an anti-viral drug. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ or bone marrow transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Ganciclovir is also used to treat people with weakened immune systems (including people with AIDS) who have CMV retinitis. Ganciclovir works by slowing the growth of the CMV virus. It helps control CMV retinitis and decrease the risk of blindness. It also helps prevent the spread of infection to other areas of the body. Ganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.

NDC Code Structure

  • 76233 - Laboratorio Reig Jofre, S.a.

NDC 76233-072-94

Package Description: 25 VIAL in 1 CARTON > 10 mL in 1 VIAL (76233-072-10)

NDC Product Information

Ganciclovir with NDC 76233-072 is a a human prescription drug product labeled by Laboratorio Reig Jofre, S.a.. The generic name of Ganciclovir is ganciclovir sodium. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

Labeler Name: Laboratorio Reig Jofre, S.a.

Dosage Form: Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.

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.

Ganciclovir 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.

  • GANCICLOVIR SODIUM 500 mg/10mL

Administration Route(s)

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

  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • DNA Polymerase Inhibitors - [MoA] (Mechanism of Action)
  • Nucleoside Analog - [EXT]
  • Nucleoside Analog Antiviral - [EPC] (Established Pharmacologic Class)

Product Labeler Information

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

Labeler Name: Laboratorio Reig Jofre, S.a.
Labeler Code: 76233
FDA Application Number: ANDA207815 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.

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.

Start Marketing Date: 08-25-2020 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 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’.

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