ganciclovir

Generic: ganciclovir sodium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganciclovir
Generic Name ganciclovir sodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ganciclovir sodium 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9299
Product ID 0143-9299_192fd7cc-3a38-4afe-82f3-a4d89238b1ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076222
Listing Expiration 2026-12-31
Marketing Start 2021-06-17

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 01439299
Hyphenated Format 0143-9299

Supplemental Identifiers

RxCUI
310442
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 ANDA076222 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (0143-9299-10) / 10 mL in 1 VIAL (0143-9299-01)
source: ndc

Packages (1)

0143-9299-10 10 VIAL in 1 BOX (0143-9299-10) / 10 mL in 1 VIAL (0143-9299-01)

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": "192fd7cc-3a38-4afe-82f3-a4d89238b1ad", "openfda": {"unii": ["02L083W284"], "rxcui": ["310442"], "spl_set_id": ["4f8219ca-6780-4131-8962-9c3fdd0a84dd"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (0143-9299-10)  / 10 mL in 1 VIAL (0143-9299-01)", "package_ndc": "0143-9299-10", "marketing_start_date": "20210617"}], "brand_name": "Ganciclovir", "product_id": "0143-9299_192fd7cc-3a38-4afe-82f3-a4d89238b1ad", "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": "0143-9299", "generic_name": "Ganciclovir sodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganciclovir", "active_ingredients": [{"name": "GANCICLOVIR SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA076222", "marketing_category": "ANDA", "marketing_start_date": "20210617", "listing_expiration_date": "20261231"}