FDA.reportPublic FDA data

ZIRGAN

Product NDC
24208-535
11-digit product format
242080535
Labeler code
24208
Product ID
24208-535_52207853-4445-f142-e063-6394a90a281c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ganciclovir
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA022211
Marketing category
NDA
Marketing start
2010-04-30
Substance
GANCICLOVIR
Active strength
1.5 mg/g
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZIRGAN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GANCICLOVIR1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP9G3CKZ4P5
Rxcui388052, 864650

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86Product name920221206
9f9c8b60-edb9-4f29-9472-12fa266e8eadProduct name520190912
db601a58-ade5-4a08-a9d0-73d4222e8e5aProduct name120170505
af7ea8c4-c902-5a51-fdbc-62597b8c28f9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-535-15ZIRGAN1.5 g in 1 TUBE, WITH APPLICATORGEL1.515
24208-535-15ZIRGAN1 in 1 CARTONGEL115
24208-535-32ZIRGAN1 in 1 CARTONGEL115
24208-535-32ZIRGAN1 g in 1 TUBE, WITH APPLICATORGEL115
24208-535-35ZIRGAN1 in 1 CARTONGEL115
24208-535-35ZIRGAN5 g in 1 TUBE, WITH APPLICATORGEL515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-535-35GM - Gram24208-53518ea2fff-1551-445b-8779-fcb030677c7612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GANCICLOVIRACTIVE INGREDIENTP9G3CKZ4P5ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]7
GANCICLOVIRACTIVE MOIETYP9G3CKZ4P5ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]7
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]7
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]7
WATERINACTIVE INGREDIENT059QF0KO0RZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-535ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]13Current NDC, Legacy NDC, 6 package rows20240229_ea25e7ac-7a93-4ec8-975b-2cec197e1c27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388052ganciclovir 0.15 % Ophthalmic GelPSNea25e7ac-7a93-4ec8-975b-2cec197e1c2715
864650Zirgan 0.15 % Ophthalmic GelPSNea25e7ac-7a93-4ec8-975b-2cec197e1c2715
864650ganciclovir 0.0015 MG/MG Ophthalmic Gel [Zirgan]SBDea25e7ac-7a93-4ec8-975b-2cec197e1c2715
388052ganciclovir 0.0015 MG/MG Ophthalmic GelSCDea25e7ac-7a93-4ec8-975b-2cec197e1c2715
388052ganciclovir 0.15 % Ophthalmic GelSYea25e7ac-7a93-4ec8-975b-2cec197e1c2715
864650Zirgan 0.0015 MG/MG Ophthalmic GelSYea25e7ac-7a93-4ec8-975b-2cec197e1c2715
864650Zirgan 0.15 % Ophthalmic GelSYea25e7ac-7a93-4ec8-975b-2cec197e1c2715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-535-15242080535151 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR2010-04-300000-00-00NoNoCurrent
24208-535-32242080535321 in 1 CARTONHistorical
24208-535-35242080535351 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR2010-04-300000-00-00NoNoCurrent