Valacyclovir Hydrochloride

Product NDC
82868-117
Requested package NDC
82868-117-21
11-digit product format
828680117
Labeler code
82868
Product ID
82868-117_5d6a592b-75fd-afa6-e063-6394a90a639e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090682
Marketing category
ANDA
Marketing start
2026-10-02
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090682-001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24
A090682-002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090682-001AB
A090682-002AB

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24c2088c7a36db…
2026-10-15 13:18:302026-09A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24c2088c7a36db…
2026-09-14 22:38:342026-08A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2484e616aacf4f…
2026-08-18 06:07:402026-07A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090682-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090682-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-244b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A090682-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A090682-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A090682-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090682-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090682-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090682-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090682-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090682-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090682-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090682-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090682-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090682-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090682-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090682-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090682-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090682-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090682-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090682-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090682-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090682-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090682-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090682-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090682-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090682-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090682-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090682-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090682-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090682-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090682-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090682-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090682-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090682-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090682-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090682-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090682-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090682-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090682-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090682-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090682-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090682-002AB14b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDECardinal Health 107, LLC72300f70-57fd-42a8-a2dc-4cf95a1ce8052026-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.de96c14b-cd74-46dd-bcce-d1fa640a60372026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDERedpharm Drug57e5cc11-f3cb-6266-e063-6394a90afc472026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f2026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepacka56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d32026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDESt. Mary's Medical Park Pharmacy275c0198-10a5-139e-e063-6394a90a72be2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepack93dccd99-d28b-4c47-872c-c3c0001b8a7f2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a888812-2867-4dd3-b56e-2d98da837d1f2026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENorthStar Rx LLC4acf51de-26f7-42b2-8acc-61b800627ef32026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDESportpharm LLC7681a6f4-a6e7-4277-adbd-38837d5ead6b2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutions8c0be4f6-2d11-41d4-8f57-4f8db9da60b22026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEMajor Pharmaceuticalsfd982aee-d503-47b3-8d3d-42e9a86904572026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutions87ec59e3-c06a-4ca7-bc65-5b251263ab3b2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutionsdf34e11d-5f2c-4755-b84b-b95d1d7b73f02026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDERising Pharma Holdings, Inc.8d1645c0-fd03-4992-9372-98026a26b3af2026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae8d15a4-1ed5-4e3c-9672-0f4735322a1c2026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e300970d-1145-4460-a8c8-f6e1654c2c3d2026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDESportpharm LLC458bb24a-4f97-4003-93cb-356906a432c92026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENorthwind Health Company, LLCf32d5f04-4198-82a5-e053-2995a90a18412026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENorthwind Health Company, LLCf98aea50-e4d9-c0cc-e053-6294a90a811c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090682
application number: ANDA090682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82868-117-218286801172121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-117-21) 2026-10-02NoNoCurrent