ganciclovir

Generic: ganciclovir sodium

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganciclovir
Generic Name ganciclovir sodium
Labeler slate run pharmaceuticals, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ganciclovir sodium 500 mg/10mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-089
Product ID 70436-089_2c55a80a-e482-1d6b-e063-6394a90a41c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204204
Listing Expiration 2026-12-31
Marketing Start 2019-01-01

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 70436089
Hyphenated Format 70436-089

Supplemental Identifiers

RxCUI
310442
UPC
0370436089550
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 ANDA204204 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (70436-089-55) / 10 mL in 1 VIAL
source: ndc

Packages (1)

70436-089-55 25 VIAL in 1 CARTON (70436-089-55) / 10 mL in 1 VIAL

Ingredients (1)

ganciclovir sodium (500 mg/10mL)

Linked Drug Pages (1)

ganciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2c55a80a-e482-1d6b-e063-6394a90a41c4", "openfda": {"upc": ["0370436089550"], "unii": ["02L083W284"], "rxcui": ["310442"], "spl_set_id": ["eb100366-2a64-4742-af11-6177a8a494c8"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (70436-089-55)  / 10 mL in 1 VIAL", "package_ndc": "70436-089-55", "marketing_start_date": "20190101"}], "brand_name": "ganciclovir", "product_id": "70436-089_2c55a80a-e482-1d6b-e063-6394a90a41c4", "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": "70436-089", "generic_name": "ganciclovir sodium", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ganciclovir", "active_ingredients": [{"name": "GANCICLOVIR SODIUM", "strength": "500 mg/10mL"}], "application_number": "ANDA204204", "marketing_category": "ANDA", "marketing_start_date": "20190101", "listing_expiration_date": "20261231"}