Home NDC 65841-629 Valacyclovir
Product NDC 65841-629
11-digit product format 658410629
Labeler code 65841
Product ID 65841-629_aa80b623-2abf-418e-bded-79666b225353
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA079137
Marketing category ANDA
Marketing start 2018-04-05
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 65841-629 VALACYCLOVIR TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 4 Legacy NDC 20221109_91832fd8-0d76-4408-9d26-9d5f52c47670.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65841-629-01 65841062901 100 TABLET, FILM COATED in 1 BOTTLE (65841-629-01) 2018-04-05 0000-00-00 No No Current 65841-629-06 65841062906 30 TABLET, FILM COATED in 1 BOTTLE (65841-629-06) 2018-04-05 0000-00-00 No No Current 65841-629-10 65841062910 1000 TABLET, FILM COATED in 1 BOTTLE (65841-629-10) 2018-04-05 0000-00-00 No No Current 65841-629-77 65841062977 10 BLISTER PACK in 1 CARTON (65841-629-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-629-30) 10 blister pack 2018-04-05 0000-00-00 No No Current