FDA.reportPublic FDA data

Acyclovir

Product NDC
50090-0596
11-digit product format
500900596
Labeler code
50090
Product ID
50090-0596_95392439-7b7c-481c-bdab-f6bcd49c6d68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075090
Marketing category
ANDA
Marketing start
2009-10-22
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
200 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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0596-02023-01-30C16284748780-1f386c649-b1bc-0266-e053-dadaa90a7c1aAcyclovir Capsules USP
50090-0596-12023-01-30C16284748780-1f386c649-b1bc-0266-e053-dadaa90a7c1aAcyclovir Capsules USP
50090-0596-72023-01-30C16284748780-1f386c649-b1bc-0266-e053-dadaa90a7c1aAcyclovir Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0596-0Acyclovir25 in 1 BOTTLECAPSULE2513
50090-0596-1Acyclovir50 in 1 BOTTLECAPSULE5013
50090-0596-7Acyclovir30 in 1 BOTTLECAPSULE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0596-0EA - Each50090-0596789dc9db-b098-4218-9d29-128cca8673c712018-08-13
50090-0596-1EA - Each50090-05960386721d-b4fe-44ac-bc5f-2d39344e1c9912018-09-05
50090-0596-7EA - Each50090-0596bdc7cc85-3140-4170-b365-f32b25f8a8b412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0596ACYCLOVIR CAPSULE [A-S MEDICATION SOLUTIONS]13Legacy NDC, 3 package rows20210206_4267ebef-e40e-4d3e-aac1-51b767e66272.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN4267ebef-e40e-4d3e-aac1-51b767e6627213
197310acyclovir 200 MG Oral CapsuleSCD4267ebef-e40e-4d3e-aac1-51b767e6627213
197310acycycloguanosine 200 MG Oral CapsuleSY4267ebef-e40e-4d3e-aac1-51b767e6627213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0596-05009005960025 CAPSULE in 1 BOTTLE (50090-0596-0) 25 capsule2014-11-280000-00-00NoNoCurrent
50090-0596-15009005960150 CAPSULE in 1 BOTTLE (50090-0596-1) 50 capsule2014-11-280000-00-00NoNoCurrent
50090-0596-75009005960730 CAPSULE in 1 BOTTLE (50090-0596-7) 30 capsule2014-11-280000-00-00NoNoCurrent