FDA.report

Valacyclovir Hydrochloride

Product NDC
65862-449
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090682
Marketing category
ANDA
Substance
VALACYCLOVIR HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
65862-449-01100 TABLET, FILM COATED in 1 BOTTLE (65862-449-01) 20100524NoHistorical
65862-449-05500 TABLET, FILM COATED in 1 BOTTLE (65862-449-05) 20100524NoHistorical
65862-449-151500 TABLET, FILM COATED in 1 BOTTLE (65862-449-15) 20100524NoHistorical
65862-449-3030 TABLET, FILM COATED in 1 BOTTLE (65862-449-30) 20100524NoHistorical
65862-449-9090 TABLET, FILM COATED in 1 BOTTLE (65862-449-90) 20100524NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
458bb24a-4f97-4003-93cb-356906a432c9These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995Sportpharm LLC2026-02-05HUMAN PRESCRIPTION DRUG LABEL5
fb875f07-e9a0-48eb-a8b0-16ea7bbae9abThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995Proficient Rx LP2026-01-01HUMAN PRESCRIPTION DRUG LABEL4
f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995Aurobindo Pharma Limited | Aurolife Pharma LLC | APL HEALTHCARE LIMITED2025-12-04Human Prescription Drug Label17
7f5fc62f-d043-db36-ce92-7adc4f7a79a5Valacyclovir Tablets, USP These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995AvPAK2025-10-15HUMAN PRESCRIPTION DRUG LABEL7
23fb4162-2310-486c-ba9f-f7c94b793e56These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995American Health Packaging2025-01-08HUMAN PRESCRIPTION DRUG LABEL9
96279db3-8e8f-157c-e053-2995a90a2e78valacyclovir 1gmRedPharm Drug, Inc.2024-08-26HUMAN PRESCRIPTION DRUG LABEL6
1864bf8b-07a2-4b82-8592-bf8ad6f9f8f9These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-07-11HUMAN PRESCRIPTION DRUG LABEL2
7f5fc62f-d043-db36-ce92-7adc4f7a79a5Valacyclovir Tablets, USP These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995AvPAK2022-05-06HUMAN PRESCRIPTION DRUG LABEL6
0ad6d733-ecbb-4578-962c-a88fd13e0f6cThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995A-S Medication Solutions2021-06-14Human Prescription Drug Label7