GANCICLOVIR

Product NDC
63304-637
11-digit product format
633040637
Labeler code
63304
Product ID
63304-637_3406db8a-5ae9-4120-94bd-036701adbeca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GANCICLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076457
Marketing category
ANDA
Marketing start
2003-08-27
Marketing end
0000-00-00
Substance
GANCICLOVIR
Active strength
500 mg/1
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63304-637IInactivated by FDA2026-08-03
excluded packagepackage63304-63763304-637-05IInactivated by FDA2026-08-03
excluded packagepackage63304-63763304-637-28IInactivated by FDA2026-08-03
excluded packagepackage63304-63763304-637-60IInactivated by FDA2026-08-03
excluded packagepackage63304-63763304-637-90IInactivated by FDA2026-08-03

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-637-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-637-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-637-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-637-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-637-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-637-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-637-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-637-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-637-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-637-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-637-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-637-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-637-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-637-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-637-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-637-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-637-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-637-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-637-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-637-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-637-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-637-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-637-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-637-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-637-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-637-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-637-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-637-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-637-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-637-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-637-28ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-637-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-637-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-637-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-637-280efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-637-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-637-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-637-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-637-28ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-637-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-637-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-637-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-637-28367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-637-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-637-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-637-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-637-28557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-637-90557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076457-001GANCICLOVIRGANCICLOVIR250MGCAPSULE / ORAL2003-06-27
A076457-002GANCICLOVIRGANCICLOVIR500MGCAPSULE / ORAL2003-06-27

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076457-001GANCICLOVIR250MGCAPSULE / ORAL2003-06-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A076457-002GANCICLOVIR500MGCAPSULE / ORAL2003-06-27782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-637-05GANCICLOVIR500 in 1 BOTTLECAPSULE5001
63304-637-28GANCICLOVIR180 in 1 BOTTLECAPSULE1801
63304-637-60GANCICLOVIR60 in 1 BOTTLECAPSULE601
63304-637-90GANCICLOVIR90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-637-28EA - Each63304-63764783516-1c72-4a60-9f23-fe7525f685b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GANCICLOVIRACTIVE INGREDIENTP9G3CKZ4P5GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
GANCICLOVIRACTIVE MOIETYP9G3CKZ4P5GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-637GANCICLOVIR CAPSULE [RANBAXY PHARMACEUTICALS INC.]1Legacy NDC, 4 package rows20140710_3406db8a-5ae9-4120-94bd-036701adbeca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314007ganciclovir 250 MG Oral CapsulePSN3406db8a-5ae9-4120-94bd-036701adbeca1
200206ganciclovir 500 MG Oral CapsulePSN3406db8a-5ae9-4120-94bd-036701adbeca1
314007ganciclovir 250 MG Oral CapsuleSCD3406db8a-5ae9-4120-94bd-036701adbeca1
200206ganciclovir 500 MG Oral CapsuleSCD3406db8a-5ae9-4120-94bd-036701adbeca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-637-0563304063705500 in 1 BOTTLEHistorical
63304-637-2863304063728180 in 1 BOTTLEHistorical
63304-637-606330406376060 in 1 BOTTLEHistorical
63304-637-906330406379090 in 1 BOTTLEHistorical