Valganciclovir

Product NDC
16714-765
11-digit product format
167140765
Labeler code
16714
Product ID
16714-765_d66fef85-c126-b5a3-38ba-a9d3b6370b5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA203511
Marketing category
ANDA
Marketing start
2018-03-10
Marketing end
0000-00-00
Substance
VALGANCICLOVIR HYDROCHLORIDE
Active strength
450 mg/1
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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16714-765DDiscontinued by firm2026-08-03
excluded packagepackage16714-76516714-765-01DDiscontinued by firm2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct16714-765DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16714-76516714-765-01DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203511-001VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203511-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-043f01610625f2…
2019-09-15 20:21 UTC2019-09A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203511-001VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASETABLET / ORALAB2014-11-04cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203511-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203511-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203511-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203511-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203511-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203511-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203511-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203511-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203511-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203511-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203511-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203511-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203511-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203511-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203511-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203511-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203511-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203511-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203511-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203511-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203511-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203511-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203511-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203511-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203511-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203511-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203511-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203511-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203511-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203511-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203511-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203511-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203511-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203511-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203511-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203511-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203511-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203511-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203511-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203511-001AB1cb3db0bc1861…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValganciclovirVALGANCICLOVIRAmerican Health Packaging4db6dd63-e56b-45a4-86b2-ee125a1854a02026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203511
application number: ANDA203511
ValganciclovirVALGANCICLOVIRGolden State Medical Supply, Inc.79f39244-dd20-acb3-e053-2a91aa0a4aee2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203511
application number: ANDA203511
ValganciclovirVALGANCICLOVIRDr. Reddy's Laboratories Limitedf37c0780-b953-46c2-d7d4-959fc2c3e5712026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203511
application number: ANDA203511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-765-01EA - Each16714-765492e46a7-b290-479f-9cd4-5c0ce7902cac12018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-765-011671407650160 TABLET, FILM COATED in 1 BOTTLE (16714-765-01) 2018-03-100000-00-00NoNoCurrent