ganciclovir

Generic: ganciclovir sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganciclovir
Generic Name ganciclovir sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ganciclovir sodium 500 mg/10mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-315
Product ID 63323-315_41a1504e-f02c-4ec1-9650-709e945234eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090658
Listing Expiration 2027-12-31
Marketing Start 2010-06-28

Pharmacologic Class

Classes
cytomegalovirus nucleoside analog dna polymerase inhibitor [epc] dna polymerase inhibitors [moa] nucleoside analog antiviral [epc] nucleoside analog [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323315
Hyphenated Format 63323-315

Supplemental Identifiers

RxCUI
310442
UPC
0363323315016
UNII
02L083W284

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ganciclovir (source: ndc)
Generic Name ganciclovir sodium (source: ndc)
Application Number ANDA090658 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01)
source: ndc

Packages (1)

63323-315-10 25 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01)

Ingredients (1)

ganciclovir sodium (500 mg/10mL)

Linked Drug Pages (2)

Ganciclovir ndc-match (0.9) Ganciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "41a1504e-f02c-4ec1-9650-709e945234eb", "openfda": {"upc": ["0363323315016"], "unii": ["02L083W284"], "rxcui": ["310442"], "spl_set_id": ["b47f5d1c-36b8-49b6-a410-3b3f4661dde7"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-315-10)  / 10 mL in 1 VIAL (63323-315-01)", "package_ndc": "63323-315-10", "marketing_start_date": "20100628"}], "brand_name": "Ganciclovir", "product_id": "63323-315_41a1504e-f02c-4ec1-9650-709e945234eb", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "63323-315", "generic_name": "GANCICLOVIR SODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganciclovir", "active_ingredients": [{"name": "GANCICLOVIR SODIUM", "strength": "500 mg/10mL"}], "application_number": "ANDA090658", "marketing_category": "ANDA", "marketing_start_date": "20100628", "listing_expiration_date": "20271231"}