Home NDC 53002-0080 Acyclovir
Product NDC 53002-0080
11-digit product format 530020080
Labeler code 53002
Product ID 53002-0080_93f09ed7-1f40-4ec0-961d-93fe87f3f450
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA202168
Marketing category ANDA
Marketing start 2016-10-15
Marketing end 0000-00-00
Substance ACYCLOVIR
Active strength 400 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 2021-12-31
Current FDA listing Historical FDA.report record FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53002-0080-1 53002008001 15 TABLET in 1 BOTTLE (53002-0080-1) 15 tablet 2017-10-01 0000-00-00 No No Current 53002-0080-2 53002008002 20 TABLET in 1 BOTTLE (53002-0080-2) 20 tablet 2017-10-01 0000-00-00 No No Current 53002-0080-3 53002008003 21 TABLET in 1 BOTTLE (53002-0080-3) 21 tablet 2017-10-01 0000-00-00 No No Current 53002-0080-4 53002008004 30 TABLET in 1 BOTTLE (53002-0080-4) 30 tablet 2017-10-01 0000-00-00 No No Current 53002-0080-5 53002008005 35 TABLET in 1 BOTTLE (53002-0080-5) 35 tablet 2017-10-01 0000-00-00 No No Current 53002-0080-6 53002008006 50 TABLET in 1 BOTTLE (53002-0080-6) 50 tablet 2017-10-01 0000-00-00 No No Current 53002-0080-9 53002008009 60 TABLET in 1 BOTTLE (53002-0080-9) 60 tablet 2017-10-01 0000-00-00 No No Current