Home NDC 70518-3451 Valacyclovir Hydrochloride
Product NDC 70518-3451
11-digit product format 705183451
Labeler code 70518
Product ID 70518-3451_eed8d8d4-8c46-dda8-e053-2a95a90a8754
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valacyclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA078518
Marketing category ANDA
Marketing start 2022-07-14
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 2023-12-31
Current FDA listing Historical FDA.report record DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3451 VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) TABLET, FILM COATED [REMEDYREPACK INC.] 3 Legacy NDC 20240112_61865025-9528-4e28-b77c-a8bf8c968e2e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-3451-0 70518345100 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3451-0) 2022-07-14 0000-00-00 No No Current