zirgan

Generic: ganciclovir

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zirgan
Generic Name ganciclovir
Labeler bausch & lomb incorporated
Dosage Form GEL
Routes
OPHTHALMIC
Active Ingredients

ganciclovir 1.5 mg/g

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-535
Product ID 24208-535_4a193505-a7ca-c468-e063-6394a90a1824
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022211
Listing Expiration 2027-12-31
Marketing Start 2010-04-30

Pharmacologic Class

Established (EPC)
cytomegalovirus nucleoside analog dna polymerase inhibitor [epc] nucleoside analog antiviral [epc]
Mechanism of Action
dna polymerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208535
Hyphenated Format 24208-535

Supplemental Identifiers

RxCUI
388052 864650
UNII
P9G3CKZ4P5
NUI
N0000175461 N0000020060 N0000175459 N0000175466

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 zirgan (source: ndc)
Generic Name ganciclovir (source: ndc)
Application Number NDA022211 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (2)

24208-535-15 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR 24208-535-35 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

ganciclovir (1.5 mg/g)

Linked Drug Pages (1)

ZIRGAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4a193505-a7ca-c468-e063-6394a90a1824", "openfda": {"nui": ["N0000175461", "N0000020060", "N0000175459", "N0000175466"], "unii": ["P9G3CKZ4P5"], "rxcui": ["388052", "864650"], "spl_set_id": ["ea25e7ac-7a93-4ec8-975b-2cec197e1c27"], "pharm_class_epc": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog Antiviral [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15)  / 1.5 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "24208-535-15", "marketing_start_date": "20100430"}, {"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35)  / 5 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "24208-535-35", "marketing_start_date": "20100430"}], "brand_name": "ZIRGAN", "product_id": "24208-535_4a193505-a7ca-c468-e063-6394a90a1824", "dosage_form": "GEL", "pharm_class": ["Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "DNA Polymerase Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "24208-535", "generic_name": "ganciclovir", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZIRGAN", "active_ingredients": [{"name": "GANCICLOVIR", "strength": "1.5 mg/g"}], "application_number": "NDA022211", "marketing_category": "NDA", "marketing_start_date": "20100430", "listing_expiration_date": "20271231"}