Valacyclovir

Product NDC
55700-913
11-digit product format
557000913
Labeler code
55700
Product ID
55700-913_66071adc-f000-4826-b07c-122ec16b806e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
Marketing end
0000-00-00
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
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 productproduct55700-913DDiscontinued by firm2026-08-03
excluded packagepackage55700-91355700-913-21DDiscontinued 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 · 4 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 packagepackage55700-913-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-913-21f5e01cc5f278…a2eaf40c39c3…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-913-21EA - Each55700-913a71f40f4-d88b-4531-9238-2c6d401c6a4812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-913VALACYCLOVIR (VALACYCLOVIR) TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]4Legacy NDC20241220_b48ed8cb-ffe9-406c-acc4-5a4802f15c36.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-913-215570009132121 TABLET, FILM COATED in 1 BOTTLE (55700-913-21) 2015-05-250000-00-00NoNoCurrent