Home NDC 53808-0635 Valacyclovir Hydrochloride
Product NDC 53808-0635
11-digit product format 538080635
Labeler code 53808
Product ID 53808-0635_2d482302-2476-4395-bcc2-53404748c889
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA077655
Marketing category ANDA
Marketing start 2013-01-01
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 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0635-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0635-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0635-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0635-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0635-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0635-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0635-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0635-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0635-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0635-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0635-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0635-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0635-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0635-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0635-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0635-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0635-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0635-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0635-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0635-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0635-1 9bebd1f3094a…5416666fcb17…
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 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 · 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 A077655-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077655-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# 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 53808-0635-1 Valacyclovir Hydrochloride 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0635 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20140415_bdd38bb5-ff30-4392-a151-5234b9342304.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0635-1 53808063501 30 in 1 BLISTER PACK Historical