Acyclovir

Product NDC
53002-0081
11-digit product format
530020081
Labeler code
53002
Product ID
53002-0081_d8313650-50c3-4889-af0f-258cc032b028
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-0081-12020-12-16C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-22020-12-16C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-32020-12-16C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-42020-12-16C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-52020-12-16C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-62020-12-16C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-92020-12-16C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-12020-01-31C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-22020-01-31C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-32020-01-31C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-42020-01-31C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-52020-01-31C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-62020-01-31C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd
53002-0081-92020-01-31C16284748780-19d75b9d0-4912-f424-e053-dadaa90a57ceea2a95c0-83ce-4f74-b1a5-64ba995253cd

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0081-15300200810115 TABLET in 1 BOTTLE (53002-0081-1) 15 tablet2018-10-010000-00-00NoNoCurrent
53002-0081-25300200810220 TABLET in 1 BOTTLE (53002-0081-2) 20 tablet2018-10-010000-00-00NoNoCurrent
53002-0081-35300200810321 TABLET in 1 BOTTLE (53002-0081-3) 21 tablet2018-10-010000-00-00NoNoCurrent
53002-0081-45300200810430 TABLET in 1 BOTTLE (53002-0081-4) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-0081-55300200810535 TABLET in 1 BOTTLE (53002-0081-5) 35 tablet2018-10-010000-00-00NoNoCurrent
53002-0081-65300200810650 TABLET in 1 BOTTLE (53002-0081-6) 50 tablet2018-10-010000-00-00NoNoCurrent
53002-0081-95300200810960 TABLET in 1 BOTTLE (53002-0081-9) 60 tablet2018-10-010000-00-00NoNoCurrent