Home NDC 21695-965 Valacyclovir Hydrochloride
Product NDC 21695-965
11-digit product format 216950965
Labeler code 21695
Product ID 21695-965_11d1e166-9577-47b0-a338-d11ab3ba44aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA077135
Marketing category ANDA
Marketing start 2010-06-11
Marketing end 0000-00-00
Substance VALACYCLOVIR HYDROCHLORIDE
Active strength 1 g/1
Pharmacologic classes Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 88 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 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 · 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 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…2022-03-09 01:35 UTC 2022-03 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077135-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2010-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077135-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2010-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077135-002 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 · 52 observed states.
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 21695-965-04 Valacyclovir Hydrochloride 4 in 1 BOTTLE TABLET, FILM COATED 4 1 21695-965-07 Valacyclovir Hydrochloride 7 in 1 BOTTLE TABLET, FILM COATED 7 1 21695-965-21 Valacyclovir Hydrochloride 21 in 1 BOTTLE TABLET, FILM COATED 21 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 [REBEL DISTRIBUTORS CORP] 1 VALACYCLOVIR ACTIVE MOIETY MZ1IW7Q79D VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-965 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 3 package rows 20111118_11d1e166-9577-47b0-a338-d11ab3ba44aa.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-965-04 21695096504 4 in 1 BOTTLE Historical 21695-965-07 21695096507 7 in 1 BOTTLE Historical 21695-965-21 21695096521 21 in 1 BOTTLE Historical