Valacyclovir Hydrochloride

Product NDC
65862-448
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
65862-448-353500 TABLET, FILM COATED in 1 BOTTLE (65862-448-35) 20100524NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
ae8d15a4-1ed5-4e3c-9672-0f4735322a1cThese 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: 1995PD-Rx Pharmaceuticals, Inc.2026-02-25HUMAN PRESCRIPTION DRUG LABEL25
e300970d-1145-4460-a8c8-f6e1654c2c3dThese 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: 1995PD-Rx Pharmaceuticals, Inc.2026-02-25HUMAN PRESCRIPTION DRUG LABEL20
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
e005139e-6f76-9b2f-e053-2a95a90ab0fbThese 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: 1995NuCare Pharmaceuticals,Inc.2024-11-08HUMAN PRESCRIPTION DRUG LABEL3
e300970d-1145-4460-a8c8-f6e1654c2c3dThese 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: 1995PD-Rx Pharmaceuticals, Inc.2024-04-25HUMAN PRESCRIPTION DRUG LABEL18
f31c6018-4eee-fb52-e053-2995a90ae764These 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: 1995NuCare Pharmaceuticals,Inc.2023-01-25HUMAN PRESCRIPTION DRUG LABEL1
e07f7cd0-53b5-9065-e053-2a95a90a0bc2These 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: 1995NuCare Pharmaceuticals,Inc.2022-06-02HUMAN PRESCRIPTION DRUG LABEL1
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