ganciclovir

Generic: ganciclovir sodium

Labeler: pharmascience inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganciclovir
Generic Name ganciclovir sodium
Labeler pharmascience inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ganciclovir sodium 500 mg/10mL

Manufacturer
Pharmascience Inc.

Identifiers & Regulatory

Product NDC 51817-171
Product ID 51817-171_f05916fd-4785-f545-e053-2995a90aa901
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207645
Listing Expiration 2026-12-31
Marketing Start 2018-04-24

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 51817171
Hyphenated Format 51817-171

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
  • 500 mg/10mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (51817-171-01) / 10 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (51817-171-02) / 10 mL in 1 VIAL
source: ndc

Packages (2)

51817-171-01 25 VIAL in 1 CARTON (51817-171-01) / 10 mL in 1 VIAL 51817-171-02 1 VIAL in 1 CARTON (51817-171-02) / 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": "f05916fd-4785-f545-e053-2995a90aa901", "openfda": {"unii": ["02L083W284"], "rxcui": ["1999531"], "spl_set_id": ["3059c2da-d4a7-4aea-828c-20e671cb875c"], "manufacturer_name": ["Pharmascience Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (51817-171-01)  / 10 mL in 1 VIAL", "package_ndc": "51817-171-01", "marketing_start_date": "20180424"}, {"sample": false, "description": "1 VIAL in 1 CARTON (51817-171-02)  / 10 mL in 1 VIAL", "package_ndc": "51817-171-02", "marketing_start_date": "20191215"}], "brand_name": "Ganciclovir", "product_id": "51817-171_f05916fd-4785-f545-e053-2995a90aa901", "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": "51817-171", "generic_name": "ganciclovir sodium", "labeler_name": "Pharmascience Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganciclovir", "active_ingredients": [{"name": "GANCICLOVIR SODIUM", "strength": "500 mg/10mL"}], "application_number": "ANDA207645", "marketing_category": "ANDA", "marketing_start_date": "20180424", "listing_expiration_date": "20261231"}