FDA.reportPublic FDA data

VALTREX

Product NDC
55289-926
11-digit product format
552890926
Labeler code
55289
Product ID
55289-926_7bbcacd0-85df-18b0-e053-2a91aa0a7fc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA020487
Marketing category
NDA
Marketing start
1995-08-01
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
500 mg/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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55289-926DDiscontinued by firm2026-07-31
excluded packagepackage55289-92655289-926-04DDiscontinued by firm2026-07-31
excluded packagepackage55289-92655289-926-06DDiscontinued by firm2026-07-31
excluded packagepackage55289-92655289-926-07DDiscontinued by firm2026-07-31
excluded packagepackage55289-92655289-926-08DDiscontinued by firm2026-07-31
excluded packagepackage55289-92655289-926-10DDiscontinued by firm2026-07-31
excluded packagepackage55289-92655289-926-14DDiscontinued by firm2026-07-31

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
N020487-001VALTREXVALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALABRLD1995-06-23
N020487-002VALTREXVALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALABRLD1995-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020487-001AB
N020487-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020487-001VALTREXEQ 500MG BASETABLET / ORALABRLD1995-06-23a50c72e98297…
2026-08-01 22:54:322026-06N020487-002VALTREXEQ 1GM BASETABLET / ORALABRLD1995-06-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020487-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N020487-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VALTREXVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.56a62c21-bead-4f3b-a24e-c3fd0b4a732f2026-07-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 020487
application number: NDA020487
VALTREXVALACYCLOVIR HYDROCHLORIDEGlaxoSmithKline LLCf8e0d8f8-cb73-4206-a484-88f5c4fbd7192025-11-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 020487
application number: NDA020487

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-926-04EA - Each55289-926afbe7d47-f7a2-4446-9e9a-27095136fba612012-07-24
55289-926-06EA - Each55289-926298138e9-adfa-4ac6-9e1f-a9faceb4291512012-07-24
55289-926-07EA - Each55289-9260864b548-73d0-4eb8-8469-c578323cca9012012-07-24
55289-926-08EA - Each55289-92677f05aca-163e-4bec-a6f0-b4011757395c12012-07-24
55289-926-10EA - Each55289-92691e61fe6-dadf-496e-838a-d8bfd2ec8b6d12012-07-24
55289-926-14EA - Each55289-926115ac1dd-6050-491b-907a-6ca989322a3112012-07-24