Home NDC 0781-5208-31 Valacyclovir Hydrochloride
Product NDC 0781-5208
Requested package NDC 0781-5208-31
11-digit product format 007815208
Labeler code 0781
Product ID 0781-5208_7ad950ff-aaff-4da0-b1ae-403d86fb06a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc.
Application ANDA077478
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 2022-12-31
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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 A077478-001 VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 A077478-002 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 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2010-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL 2010-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077478-001 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 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077478-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077478-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET [SANDOZ INC] 5 VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 VALACYCLOVIR ACTIVE MOIETY MZ1IW7Q79D VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-5208-31 00781520831 30 TABLET in 1 BOTTLE (0781-5208-31) 30 tablet 2010-05-24 0000-00-00 No No Current