Home NDC 35573-403
Acyclovir
Product NDC 35573-403
11-digit product format 355730403
Labeler code 35573
Product ID 35573-403_f9a626f6-8d1b-4186-a495-4e27d3ea8505
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form OINTMENT
Route TOPICAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA205591
Marketing category ANDA
Marketing start 2019-05-09
Marketing end 0000-00-00
Substance ACYCLOVIR
Active strength 50 mg/g
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 2021-12-31
Current FDA listing Historical FDA.report record
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35573-403-15 35573040315 1 TUBE in 1 CARTON (35573-403-15) > 15 g in 1 TUBE 1 tube 2019-05-09 0000-00-00 No No Current 35573-403-31 35573040331 1 TUBE in 1 CARTON (35573-403-31) > 30 g in 1 TUBE 1 tube 2019-05-09 0000-00-00 No No Current