Ganciclovir

Product NDC: 14335-030
Requested package NDC: 14335-030-25
11-digit product format: 143350030
Labeler code: 14335
Product ID: 14335-030_80b86c46-230e-0090-e053-2991aa0a8fc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ganciclovir sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENTRICULAR
Labeler: Hainan Poly Pharm. Co., Ltd.
Application: ANDA204204
Marketing category: ANDA
Marketing start: 2019-02-11
Marketing end: 0000-00-00
Substance: GANCICLOVIR SODIUM
Active strength: 50 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	14335-030	14335-030-25	I	Inactivated by FDA		2026-08-11

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 · 18 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A204204-001	GANCICLOVIR SODIUM	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2018-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204204-001	AP

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204204-001	GANCICLOVIR	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204204-001	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-11-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204204-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204204-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204204-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204204-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204204-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204204-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204204-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204204-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204204-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204204-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204204-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204204-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204204-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204204-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204204-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204204-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204204-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204204-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204204-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204204-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204204-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204204-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204204-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204204-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204204-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204204-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204204-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204204-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204204-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204204-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204204-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204204-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204204-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204204-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204204-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204204-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204204-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204204-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204204-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204204-001	AP	1	`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
14335-030-01	2022-01-28	C162847	48780-1	d6a99b39-4fd8-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use GANCICLOVIR for Injection, USP safely and effectively. See full prescribing information for GANCICLOVIR for Injection, USP. GANCICLOVIR for Injection, USP for intravenous use Initial U.S. Approval: 1989
14335-030-25	2022-01-28	C162847	48780-1	d6a99b39-4fd8-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use GANCICLOVIR for Injection, USP safely and effectively. See full prescribing information for GANCICLOVIR for Injection, USP. GANCICLOVIR for Injection, USP for intravenous use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
14335-030-01	Ganciclovir	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10	2
14335-030-01	Ganciclovir	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10	2
14335-030-25	Ganciclovir	25 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	25	2
14335-030-25	Ganciclovir	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14335-030	GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAINAN POLY PHARM. CO., LTD.]	2	Legacy NDC, 4 package rows	20190211_69017374-ac20-4b8c-86c7-d35907046dce.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ganciclovir	GANCICLOVIR SODIUM	Slate Run Pharmaceuticals, LLC	eb100366-2a64-4742-af11-6177a8a494c8	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204204 application number: ANDA204204
ganciclovir sodium	GANCICLOVIR SODIUM	Slate Run Pharmaceuticals, LLC	cd293b9d-b573-4656-8574-19d7db870a9b	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204204 application number: ANDA204204

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
02L083W284	GANCICLOVIR SODIUM	107910-75-8	GANCICLOVIR SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310442	ganciclovir 500 MG Injection	PSN	69017374-ac20-4b8c-86c7-d35907046dce	2
310442	ganciclovir 500 MG Injection	SCD	69017374-ac20-4b8c-86c7-d35907046dce	2
310442	ganciclovir 500 MG (as ganciclovir sodium) Injection	SY	69017374-ac20-4b8c-86c7-d35907046dce	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
14335-030-25	14335003025	25 VIAL in 1 CARTON (14335-030-25) > 10 mL in 1 VIAL	25 vial	2019-02-11	0000-00-00	No	No	Current