NDC 63304-636 Ganciclovir

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
63304-636
Proprietary Name:
Ganciclovir
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Ranbaxy Pharmaceuticals Inc.
Labeler Code:
63304
Start Marketing Date: [9]
08-27-2003
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329 - OPAQUE GREEN CAP & BODY)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
RX636
Score:
1

Product Packages

NDC Code 63304-636-10

Package Description: 1000 CAPSULE in 1 BOTTLE

NDC Code 63304-636-28

Package Description: 180 CAPSULE in 1 BOTTLE

NDC Code 63304-636-60

Package Description: 60 CAPSULE in 1 BOTTLE

NDC Code 63304-636-90

Package Description: 90 CAPSULE in 1 BOTTLE

Product Details

What is NDC 63304-636?

The NDC code 63304-636 is assigned by the FDA to the product Ganciclovir which is product labeled by Ranbaxy Pharmaceuticals Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 63304-636-10 1000 capsule in 1 bottle , 63304-636-28 180 capsule in 1 bottle , 63304-636-60 60 capsule in 1 bottle , 63304-636-90 90 capsule in 1 bottle . 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 Ganciclovir?

Ganciclovir capsules are indicated for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Ganciclovir capsules are also indicated as an alternative to the intravenous formulation for maintenance treatment of CMV retinitis in immunocompromised patients, including patients with AIDS, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily IV infusions (see CLINICAL TRIALS).SAFETY AND EFFICACY OF GANCICLOVIR HAVE NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE; NOT FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS. THE SAFETY AND EFFICACY OF GANCICLOVIR CAPSULES HAVE NOT BEEN ESTABLISHED FOR TREATING ANY MANIFESTATION OF CMV DISEASE OTHER THAN MAINTENANCE TREATMENT OF CMV RETINITIS.

Which are Ganciclovir UNII Codes?

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

Which are Ganciclovir 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 Ganciclovir?

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:

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Product Footnotes

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

[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".