Valganciclovir

Product NDC
68084-965
11-digit product format
680840965
Labeler code
68084
Product ID
68084-965_22ca12d3-7404-28f7-e063-6394a90a94bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203511
Marketing category
ANDA
Marketing start
2015-01-07
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
2026-12-31
Current FDA listing
Yes

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
ndc (product): 68084-965
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE450 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4P3T9QF9NZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313566Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4db6dd63-e56b-45a4-86b2-ee125a1854a0Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-965-18Valganciclovir1 in 1 BLISTER PACKTABLET, FILM COATED17
68084-965-19Valganciclovir20 in 1 CARTONTABLET, FILM COATED207
68084-965-25Valganciclovir30 in 1 BOX, UNIT-DOSETABLET, FILM COATED307
68084-965-95Valganciclovir1 in 1 BLISTER PACKTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-965-18EA - Each68084-965f2ec7b19-7949-4bef-abbb-f5f57c5c181312024-10-04
68084-965-19EA - Each68084-96549fd3786-0775-40b3-9cd5-287b71e4c19812024-10-04
68084-965-25EA - Each68084-96513fa8694-1f0c-43fc-9e89-cdf4faf24a4712015-02-02
68084-965-95EA - Each68084-965c03a6ea6-bd94-46db-bbdf-1a5d80f729cd12015-02-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-965VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 4 package rows20240925_4db6dd63-e56b-45a4-86b2-ee125a1854a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN4db6dd63-e56b-45a4-86b2-ee125a1854a07
313566valganciclovir 450 MG Oral TabletSCD4db6dd63-e56b-45a4-86b2-ee125a1854a07
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY4db6dd63-e56b-45a4-86b2-ee125a1854a07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-965-18680840965181 in 1 BLISTER PACKHistorical
68084-965-196808409651920 BLISTER PACK in 1 CARTON (68084-965-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18) 20 blister pack2024-09-22NoNoCurrent
68084-965-256808409652530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95) 30 blister pack2015-01-160000-00-00NoNoCurrent
68084-965-95680840965951 in 1 BLISTER PACKHistorical