Home NDC 50436-0153 Valacyclovir hydrochloride
Product NDC 50436-0153
11-digit product format 504360153
Labeler code 50436
Product ID 50436-0153_97b96672-f19d-4b09-93eb-556cd1bc1898
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir hydrochloride
Dosage form TABLET
Route ORAL
Labeler Unit Dose Services
Application ANDA077135
Marketing category ANDA
Marketing start 2010-05-24
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 2020-12-31
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 2 · 114 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077135-001 VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 A077135-002 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 · 86 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 2026-09-14 22:38:34 2026-08 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 50436-0153-1 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 50436-0153-3 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 50436-0153-4 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 50436-0153-5 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 50436-0153-6 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-0153-1 Valacyclovir hydrochloride 30 in 1 BOTTLE TABLET 30 3 50436-0153-3 Valacyclovir hydrochloride 90 in 1 BOTTLE TABLET 90 3 50436-0153-4 Valacyclovir hydrochloride 12 in 1 BOTTLE TABLET 12 3 50436-0153-5 Valacyclovir hydrochloride 15 in 1 BOTTLE TABLET 15 3 50436-0153-6 Valacyclovir hydrochloride 24 in 1 BOTTLE TABLET 24 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-0153 VALACYCLOVIR HYDROCHLORIDE TABLET [UNIT DOSE SERVICES] 3 Legacy NDC, 5 package rows 20190507_3331ed10-1d2b-4c88-ad2d-881f7f476198.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-0153-1 50436015301 30 in 1 BOTTLE Historical 50436-0153-3 50436015303 90 in 1 BOTTLE Historical 50436-0153-4 50436015304 12 in 1 BOTTLE Historical 50436-0153-5 50436015305 15 in 1 BOTTLE Historical 50436-0153-6 50436015306 24 in 1 BOTTLE Historical