Home NDC 70518-2039-1 VALTREX
Product NDC 70518-2039
Requested package NDC 70518-2039-1
11-digit product format 705182039
Labeler code 70518
Product ID 70518-2039_5d17e1fe-3e7c-5dca-e063-6394a90a7a90
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 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-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 · 88 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 2026-10-15 13:18:30 2026-09 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD 1995-06-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD 1995-06-23 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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 VALTREX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALACYCLOVIR HYDROCHLORIDE 1 g/1
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VALTREX VALACYCLOVIR HYDROCHLORIDE GlaxoSmithKline LLC f8e0d8f8-cb73-4206-a484-88f5c4fbd719 2025-11-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 020487 application number: NDA020487
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-2039-1 70518203901 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-1) 2023-07-17 No No Current