NDC 0004-0039 Valcyte
Valganciclovir Hydrochloride Powder, For Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Get all the details for National Drug Code (NDC) 0004-0039 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.
Product Characteristics
WHITE (C48325 - COLORLESS TO BROWNISH YELLOW)
Code Structure Chart
Product Details
What is NDC 0004-0039?
What are the uses for Valcyte?
What are Valcyte Active Ingredients?
- VALGANCICLOVIR HYDROCHLORIDE 50 mg/mL - A ganciclovir prodrug and antiviral agent that is used to treat CYTOMEGALOVIRUS RETINITIS in patients with AIDS, and for the prevention of CYTOMEGALOVIRUS INFECTIONS in organ transplant recipients who have received an organ from a CMV-positive donor.
Which are Valcyte UNII Codes?
The UNII codes for the active ingredients in this product are:
- VALGANCICLOVIR HYDROCHLORIDE (UNII: 4P3T9QF9NZ)
- GANCICLOVIR (UNII: P9G3CKZ4P5) (Active Moiety)
Which are Valcyte 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:
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POVIDONE K30 (UNII: U725QWY32X)
- CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- FUMARIC ACID (UNII: 88XHZ13131)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
- MANNITOL (UNII: 3OWL53L36A)
- MALTODEXTRIN (UNII: 7CVR7L4A2D)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- ACACIA (UNII: 5C5403N26O)
What is the NDC to RxNorm Crosswalk for Valcyte?
- RxCUI: 284587 - Valcyte 450 MG Oral Tablet
- RxCUI: 284587 - valganciclovir 450 MG Oral Tablet [Valcyte]
- RxCUI: 284587 - Valcyte 450 MG (valganciclovir hydrochloride 496.3 MG) Oral Tablet
- RxCUI: 313566 - valGANciclovir HCl 450 MG Oral Tablet
- RxCUI: 313566 - valganciclovir 450 MG Oral Tablet
Which are the Pharmacologic Classes for Valcyte?
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Patient Education
Valganciclovir
Valganciclovir is used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people who have acquired immunodeficiency syndrome (AIDS). Valganciclovir is also used to prevent cytomegalovirus (CMV) disease in people who have received a heart, kidney, or kidney-pancreas transplant and who have a chance of getting CMV disease. Valganciclovir is in a class of medications called antivirals. It works by preventing the spread of CMV disease or slowing the growth of CMV.
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[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.
[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".