Valacyclovir

Product NDC
70518-2402
11-digit product format
705182402
Labeler code
70518
Product ID
70518-2402_4def1240-9140-8d84-e063-6294a90a788f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203047
Marketing category
ANDA
Marketing start
2019-11-04
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1 g/1
Pharmacologic classes
DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-240270518-2402-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-240270518-2402-1DDiscontinued by firm2026-08-03
excluded packagepackage70518-240270518-2402-2DDiscontinued by firm2026-08-03
excluded packagepackage70518-240270518-2402-3DDiscontinued by firm2026-08-03
excluded packagepackage70518-240270518-2402-4DDiscontinued by firm2026-08-03
excluded packagepackage70518-240270518-2402-5DDiscontinued by firm2026-08-03
excluded packagepackage70518-240270518-2402-6DDiscontinued 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 · 29 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-2402-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2402-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2402-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2402-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2402-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2402-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-2402-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2402-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2402-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2402-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2402-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2402-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-2402-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170518-2402-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-2402-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870518-2402-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-2402-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170518-2402-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-2402-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070518-2402-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-2402-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170518-2402-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-2402-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070518-2402-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-2402-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070518-2402-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-2402-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-2402-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-2402-0557ba5c1ecfa…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
A203047-001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08
A203047-002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALABRS2015-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203047-001AB
A203047-002AB

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 UTC2026-02A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203047-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2015-04-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A203047-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2015-04-08782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203047-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203047-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203047-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203047-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203047-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203047-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203047-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203047-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203047-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203047-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203047-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203047-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203047-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203047-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203047-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203047-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203047-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203047-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203047-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203047-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203047-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203047-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203047-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203047-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203047-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203047-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203047-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203047-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203047-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203047-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203047-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203047-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203047-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203047-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203047-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203047-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203047-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203047-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203047-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203047-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G447S0T1VCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c332401-afb6-455b-b61a-ea108a377ef6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2402-0Valacyclovir4 in 1 BOTTLE, PLASTICTABLET, FILM COATED414
70518-2402-1Valacyclovir4 in 1 BOTTLE, PLASTICTABLET, FILM COATED414
70518-2402-2Valacyclovir21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2114
70518-2402-3Valacyclovir15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1514
70518-2402-4Valacyclovir14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1414
70518-2402-5Valacyclovir7 in 1 BOTTLE, PLASTICTABLET, FILM COATED714
70518-2402-6Valacyclovir30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
70518-2402-7Valacyclovir7 in 1 BOTTLE, PLASTICTABLET, FILM COATED714

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2402VALACYCLOVIR TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 8 package rows20250216_7c332401-afb6-455b-b61a-ea108a377ef6.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValacyclovirVALACYCLOVIRREMEDYREPACK INC.7c332401-afb6-455b-b61a-ea108a377ef62026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ndc (product): 70518-2402
ValacyclovirVALACYCLOVIRSt Mary's Medical Park Pharmacybed99bed-3904-5278-e053-2a95a90aeab62026-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRPD-Rx Pharmaceuticals, Inc.1b11361c-5444-498b-ab7c-fbad917705ae2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRCoupler LLC5100ef9f-6dc2-fa06-e063-6294a90accd02026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRCoupler LLC50237c2d-99e8-9899-e063-6394a90a468c2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRNuCare Pharmaceuticals,Inc.84601168-8829-f4a3-e053-2991aa0a3c202026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRPD-Rx Pharmaceuticals, Inc.e6f54a83-eb07-49d6-b93a-6fe94db323b82026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRA-S Medication Solutions69301126-c901-4d0d-9acb-91ba1a87cd212026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRA-S Medication Solutions4ab809f3-8898-463c-b55a-f452c87d07792026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRQuallent Pharmaceuticals Health LLC764b0cf9-9207-404c-87a8-a1e0109af6cc2026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRCamber Pharmaceuticals, Inc.7f5e96e0-534c-47a5-bb79-926088afc73c2025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRPreferred Pharmaceuticals, Inc.7abc96b9-8f34-4fda-b5bb-1bdf23c1e1352025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRNuCare Pharmaceuticals, Inc.296c04dc-2c64-4784-e063-6294a90ae6a32025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRREMEDYREPACK INC.2c2d5cec-038f-42bb-8f04-90d2431dc1c92025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRNuCare Pharmaceuticals, Inc.3aff1f5e-d92b-686b-e063-6294a90a29952025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRProficient Rx LP90a67c02-edce-44aa-8d3a-d819313acc262025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRNuCare Pharmaceuticals, Inc.29a6b4ec-3e23-289b-e063-6394a90a11572024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRBryant Ranch Prepacke5f5223f-569c-40c6-a3c7-381bc61cf8c62024-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047
ValacyclovirVALACYCLOVIRProficient Rx LP8794a786-245a-42a3-b33a-9b0ed1dd46ac2023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203047
application number: ANDA203047

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir 1000 MG Oral TabletSCD7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir 1 GM Oral TabletSY7c332401-afb6-455b-b61a-ea108a377ef614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2402-0705182402004 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2402-0) 2019-11-040000-00-00NoNoCurrent
70518-2402-1705182402014 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2402-1) 2022-10-140000-00-00NoNoCurrent
70518-2402-27051824020221 in 1 BOTTLE, PLASTICHistorical
70518-2402-37051824020315 in 1 BOTTLE, PLASTICHistorical
70518-2402-47051824020414 in 1 BOTTLE, PLASTICHistorical
70518-2402-5705182402057 in 1 BOTTLE, PLASTICHistorical
70518-2402-67051824020630 in 1 BOTTLE, PLASTICHistorical
70518-2402-7705182402077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2402-7) 2025-02-14NoNoCurrent