Home NDC 0093-7259 Valacyclovir
Product NDC 0093-7259
11-digit product format 000937259
Labeler code 0093
Product ID 0093-7259_84ea32d8-7235-4cb0-b53d-a6b7040ba28b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA077655
Marketing category ANDA
Marketing start 2010-05-24
Marketing end 2020-07-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077655-001 VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 A077655-002 VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24
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 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 7 VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1
DailyMed RxNorm Mappings#