Home NDC 0173-0933 VALTREX
Product NDC 0173-0933
11-digit product format 001730933
Labeler code 0173
Product ID 0173-0933_753fde77-5750-4c98-a167-daa531f3d872
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valacyclovir hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA020487
Marketing category NDA
Marketing start 1995-08-01
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 2026-12-31
Current FDA listing Yes 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-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 · 82 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 2026-02-19 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…2021-12-28 21:50 UTC 2021-12 N020487-001 VALTREX EQ 500MG BASE TABLET / ORAL AB RLD 1995-06-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020487-002 VALTREX EQ 1GM BASE TABLET / ORAL AB RLD, RS 1995-06-23 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 500 mg/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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 108780 Internal RxNorm lookup 212448 Internal RxNorm lookup 313564 Internal RxNorm lookup 313565 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0173-0933-08 VALTREX 30 in 1 BOTTLE TABLET, FILM COATED 30 31 0173-0933-10 VALTREX 90 in 1 BOTTLE TABLET, FILM COATED 90 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 POVIDONES INACTIVE INGREDIENT FZ989GH94E VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 16 VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0173-0933 VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 29 Current NDC, Legacy NDC, 2 package rows 20240625_f8e0d8f8-cb73-4206-a484-88f5c4fbd719.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 0173-0933-08 00173093308 30 TABLET, FILM COATED in 1 BOTTLE (0173-0933-08) 1995-08-01 0000-00-00 No No Current 0173-0933-10 00173093310 90 TABLET, FILM COATED in 1 BOTTLE (0173-0933-10) 1995-08-01 0000-00-00 No No Current 0173-0933-56 00173093356 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0173-0933-56) 1995-08-01 0000-00-00 No No Current