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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24208-535	24208-535-32	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022211-001	ZIRGAN	GANCICLOVIR	0.15%	GEL / OPHTHALMIC		RLD, RS	2009-09-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022211-001	ZIRGAN	0.15%	GEL / OPHTHALMIC	RLD, RS	2009-09-15	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GANCICLOVIR	1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P9G3CKZ4P5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
388052	Internal RxNorm lookup
864650	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ea25e7ac-7a93-4ec8-975b-2cec197e1c27	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86	Product name	9	20221206
9f9c8b60-edb9-4f29-9472-12fa266e8ead	Product name	5	20190912
db601a58-ade5-4a08-a9d0-73d4222e8e5a	Product name	1	20170505
af7ea8c4-c902-5a51-fdbc-62597b8c28f9	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-535-15	ZIRGAN	1.5 g in 1 TUBE, WITH APPLICATOR	GEL	1.5	15
24208-535-15	ZIRGAN	1 in 1 CARTON	GEL	1	15
24208-535-32	ZIRGAN	1 in 1 CARTON	GEL	1	15
24208-535-32	ZIRGAN	1 g in 1 TUBE, WITH APPLICATOR	GEL	1	15
24208-535-35	ZIRGAN	1 in 1 CARTON	GEL	1	15
24208-535-35	ZIRGAN	5 g in 1 TUBE, WITH APPLICATOR	GEL	5	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-535-35	GM - Gram	24208-535	18ea2fff-1551-445b-8779-fcb030677c76	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GANCICLOVIR	ACTIVE INGREDIENT	P9G3CKZ4P5	ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]	7
GANCICLOVIR	ACTIVE MOIETY	P9G3CKZ4P5	ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]	7
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]	7
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	HHT01ZNK31	ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-535	ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]	13	Current NDC, Legacy NDC, 6 package rows	20240229_ea25e7ac-7a93-4ec8-975b-2cec197e1c27.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZIRGAN	GANCICLOVIR	Bausch & Lomb Incorporated	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022211 application number: NDA022211 ndc (product): 24208-535

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P9G3CKZ4P5	GANCICLOVIR	82410-32-0	GANCICLOVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
388052	ganciclovir 0.15 % Ophthalmic Gel	PSN	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	15
864650	Zirgan 0.15 % Ophthalmic Gel	PSN	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	15
864650	ganciclovir 0.0015 MG/MG Ophthalmic Gel [Zirgan]	SBD	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	15
388052	ganciclovir 0.0015 MG/MG Ophthalmic Gel	SCD	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	15
388052	ganciclovir 0.15 % Ophthalmic Gel	SY	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	15
864650	Zirgan 0.0015 MG/MG Ophthalmic Gel	SY	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	15
864650	Zirgan 0.15 % Ophthalmic Gel	SY	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-535-15	24208053515	1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR	2010-04-30	0000-00-00	No	No	Current
24208-535-32	24208053532	1 in 1 CARTON					Historical
24208-535-35	24208053535	1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR	2010-04-30	0000-00-00	No	No	Current