ganciclovir

Generic: ganciclovir sodium

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganciclovir
Generic Name ganciclovir sodium
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ganciclovir sodium 50 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-185
Product ID 25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207645
Listing Expiration 2026-12-31
Marketing Start 2018-02-15

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 25021185
Hyphenated Format 25021-185

Supplemental Identifiers

RxCUI
1999531
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 ANDA207645 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (25021-185-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

25021-185-10 25 VIAL in 1 CARTON (25021-185-10) / 10 mL in 1 VIAL

Ingredients (1)

ganciclovir sodium (50 mg/mL)

Linked Drug Pages (1)

ganciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "696f706f-39d7-4647-a506-2ebf7b956cc1", "openfda": {"unii": ["02L083W284"], "rxcui": ["1999531"], "spl_set_id": ["993151ed-cea7-49a7-a967-fac3e9b3c85f"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (25021-185-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-185-10", "marketing_start_date": "20180215"}], "brand_name": "ganciclovir", "product_id": "25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "25021-185", "generic_name": "ganciclovir sodium", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ganciclovir", "active_ingredients": [{"name": "GANCICLOVIR SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA207645", "marketing_category": "ANDA", "marketing_start_date": "20180215", "listing_expiration_date": "20261231"}