GANCICLOVIR

Product NDC: 51754-2500
Requested package NDC: 51754-2500-3
11-digit product format: 517542500
Labeler code: 51754
Product ID: 51754-2500_238a983f-81bb-4033-b6ca-5fee7d6d291c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GANCICLOVIR
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: EXELA PHARMA SCIENCES, LLC
Application: NDA209347
Marketing category: NDA
Marketing start: 2017-02-28
Marketing end: 0000-00-00
Substance: GANCICLOVIR
Active strength: 2 mg/mL
Pharmacologic classes: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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	51754-2500	51754-2500-3	I	Inactivated by FDA		2026-08-03

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
N209347-001	GANZYK-RTU	GANCICLOVIR	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS		RLD	2017-02-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209347-001	9486530	2034-09-02		Drug product	2017-04-04

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	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209347-001	GANCICLOVIR	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209347-001	GANCICLOVIR	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209347-001	GANZYK-RTU	500MG/250ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-17	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209347-001	9486530	2034-09-02	Drug product	2017-04-04	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51754-2500-1	2026-01-29	C162847	48780-1	49896155-b99d-586f-e063-e6dba90add90	These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR INJECTION, for intravenous use Initial U.S. Approval: 1989
51754-2500-3	2026-01-29	C162847	48780-1	49896155-b99d-586f-e063-e6dba90add90	These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR INJECTION, for intravenous use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51754-2500-1	GANCICLOVIR	250 mL in 1 BAG	INJECTION, SOLUTION	250	3
51754-2500-3	GANCICLOVIR	250 mL in 1 BAG	INJECTION, SOLUTION	250	3
51754-2500-3	GANCICLOVIR	10 in 1 POUCH	INJECTION, SOLUTION	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51754-2500-1	ML - Milliliter	51754-2500	46998e8e-d9b1-41b5-944e-8e26b94c75e3	1	2017-06-15
51754-2500-3	ML - Milliliter	51754-2500	17b2495e-cecd-47cc-8652-0dee598dc697	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51754-2500	GANCICLOVIR INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]	3	Legacy NDC, 3 package rows	20171006_26361de8-39b5-4266-90f6-2b307940135d.zip

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
1872065	ganciclovir 500 MG in 250 mL Injection	PSN	26361de8-39b5-4266-90f6-2b307940135d	3
1872065	250 ML ganciclovir 2 MG/ML Injection	SCD	26361de8-39b5-4266-90f6-2b307940135d	3
1872065	ganciclovir 500 MG per 250 ML Injection	SY	26361de8-39b5-4266-90f6-2b307940135d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51754-2500-3	51754250003	10 BAG in 1 POUCH (51754-2500-3) > 250 mL in 1 BAG	10 bag	2017-02-28	0000-00-00	No	No	Current