FDA.reportPublic FDA data

acyclovir

Product NDC
50090-0642
11-digit product format
500900642
Labeler code
50090
Product ID
50090-0642_f4a12c77-9c57-4b95-8c12-b9db0e2d6639
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077309
Marketing category
ANDA
Marketing start
2007-06-09
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

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
50090-0642-02023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-12023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-22023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-32023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-42023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-52023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-62023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-72023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-82023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0642-92023-01-30C16284748780-1f386c649-a083-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0642-0acyclovir2 in 1 BOTTLETABLET23
50090-0642-1acyclovir14 in 1 BOTTLETABLET143
50090-0642-2acyclovir25 in 1 BOTTLETABLET253
50090-0642-3acyclovir50 in 1 BOTTLETABLET503
50090-0642-4acyclovir15 in 1 BOTTLETABLET153
50090-0642-5acyclovir30 in 1 BOTTLETABLET303
50090-0642-6acyclovir60 in 1 BOTTLETABLET603
50090-0642-7acyclovir500 in 1 BOTTLETABLET5003
50090-0642-8acyclovir100 in 1 BOTTLETABLET1003
50090-0642-9acyclovir45 in 1 BOTTLETABLET453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0642-2EA - Each50090-06421df7dd9a-5b9e-4c66-ba5c-e598fa5cd11c12021-08-05
50090-0642-3EA - Each50090-0642ecf729c2-8415-4310-9e7f-9a6e2bcf70d312021-08-05
50090-0642-4EA - Each50090-064215b35a01-41fd-4f65-b9b9-2d370a59233a12021-08-05
50090-0642-5EA - Each50090-0642a3501354-fe7a-4e50-b644-ef9cb732027b12021-08-05
50090-0642-6EA - Each50090-0642604c604d-ff5c-49d8-ae0b-04a324c19d9c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0642ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 10 package rows20200530_d2cd1b6d-ba7a-478b-8b06-920c239f0e35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNd2cd1b6d-ba7a-478b-8b06-920c239f0e353
197311acyclovir 400 MG Oral TabletSCDd2cd1b6d-ba7a-478b-8b06-920c239f0e353
197311acycycloguanosine 400 MG Oral TabletSYd2cd1b6d-ba7a-478b-8b06-920c239f0e353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0642-0500900642002 TABLET in 1 BOTTLE (50090-0642-0) 2 tablet2019-10-230000-00-00NoNoCurrent
50090-0642-15009006420114 TABLET in 1 BOTTLE (50090-0642-1) 14 tablet2014-11-280000-00-00NoNoCurrent
50090-0642-25009006420225 TABLET in 1 BOTTLE (50090-0642-2) 25 tablet2014-11-280000-00-00NoNoCurrent
50090-0642-35009006420350 TABLET in 1 BOTTLE (50090-0642-3) 50 tablet2014-11-280000-00-00NoNoCurrent
50090-0642-45009006420415 TABLET in 1 BOTTLE (50090-0642-4) 15 tablet2014-11-280000-00-00NoNoCurrent
50090-0642-55009006420530 TABLET in 1 BOTTLE (50090-0642-5) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0642-65009006420660 TABLET in 1 BOTTLE (50090-0642-6) 60 tablet2014-11-280000-00-00NoNoCurrent
50090-0642-750090064207500 TABLET in 1 BOTTLE (50090-0642-7) 500 tablet2019-10-230000-00-00NoNoCurrent
50090-0642-850090064208100 TABLET in 1 BOTTLE (50090-0642-8) 100 tablet2019-10-230000-00-00NoNoCurrent
50090-0642-95009006420945 TABLET in 1 BOTTLE (50090-0642-9) 45 tablet2014-11-280000-00-00NoNoCurrent