Home NDC 70518-2039 VALTREX
Product NDC 70518-2039
11-digit product format 705182039
Labeler code 70518
Product ID 70518-2039_499baba0-82b1-4029-e063-6294a90a0297
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valacyclovir hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA020487
Marketing category NDA
Marketing start 2019-04-26
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020487-001 VALTREX VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 N020487-002 VALTREX VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB RLD 1995-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD 1995-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base VALTREX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALACYCLOVIR HYDROCHLORIDE 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G447S0T1VC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 212448 Internal RxNorm lookup 313564 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-2039-0 VALTREX 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 14 70518-2039-1 VALTREX 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 14 70518-2039-2 VALTREX 5 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 5 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2039 VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.] 12 Current NDC, Legacy NDC, 3 package rows 20250523_56a62c21-bead-4f3b-a24e-c3fd0b4a732f.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-2039-0 70518203900 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-0) 2019-04-26 0000-00-00 No No Current 70518-2039-1 70518203901 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-1) 2023-07-17 No No Current 70518-2039-2 70518203902 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-2) 2023-10-02 No No Current