Home NDC 43063-778 Valacyclovir hydrochloride
Product NDC 43063-778
11-digit product format 430630778
Labeler code 43063
Product ID 43063-778_dc67d228-0f54-3832-e053-2995a90ac07d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir hydrochloride
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA077135
Marketing category ANDA
Marketing start 2010-05-24
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 Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-778 VALACYCLOVIR HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 16 Legacy NDC 20241017_91a738da-96c7-44f2-8878-df6a75abdf08.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-778-10 43063077810 10 TABLET in 1 BOTTLE, PLASTIC (43063-778-10) 10 tablet 2017-08-01 0000-00-00 No No Current 43063-778-14 43063077814 14 TABLET in 1 BOTTLE, PLASTIC (43063-778-14) 14 tablet 2017-08-11 0000-00-00 No No Current 43063-778-90 43063077890 90 TABLET in 1 BOTTLE, PLASTIC (43063-778-90) 90 tablet 2018-08-06 0000-00-00 No No Current