Home NDC 61919-066-20 Valacyclovir
Product NDC 61919-066
Requested package NDC 61919-066-20
11-digit product format 619190066
Labeler code 61919
Product ID 61919-066_364a2f8b-adfa-b8ce-e063-6394a90a8f9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Direct Rx
Application ANDA201506
Marketing category ANDA
Marketing start 2015-01-01
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 2026-12-31
Current FDA listing Yes 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 A201506-001 VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 A201506-002 VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201506-001 VALACYCLOVIR HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2012-04-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201506-002 VALACYCLOVIR HYDROCHLORIDE EQ 1GM BASE TABLET / ORAL AB 2012-04-03 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Valacyclovir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALACYCLOVIR HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G447S0T1VC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313565 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-066-20 Valacyclovir 20 in 1 BOTTLE TABLET, FILM COATED 20 3 61919-066-60 Valacyclovir 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-066 VALACYCLOVIR TABLET [DIRECT RX] 2 Current NDC, Legacy NDC, 2 package rows 20160923_cbd7bb49-7a9c-4383-a158-bfc307db0130.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 61919-066-20 61919006620 20 TABLET, FILM COATED in 1 BOTTLE (61919-066-20) 2015-01-01 No No Current