FDA.reportPublic FDA data

acyclovir

Product NDC
50090-3254
11-digit product format
500903254
Labeler code
50090
Product ID
50090-3254_3f43e431-4717-4fa0-b40f-21348c560796
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204314
Marketing category
ANDA
Marketing start
2014-09-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311

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
50090-3254-02023-02-07C16284748780-1f386c64a-1907-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3254-12023-02-07C16284748780-1f386c64a-1907-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3254-02023-01-30C16284748780-1f386c64a-1907-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3254-12023-01-30C16284748780-1f386c64a-1907-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3254-0acyclovir90 in 1 BOTTLETABLET908
50090-3254-1acyclovir21 in 1 BOTTLETABLET218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3254-0EA - Each50090-325439240ad5-143f-4cb2-972d-f80e06a71fd512019-05-02
50090-3254-1EA - Each50090-325487b34ec5-b035-4196-a9fc-9355939e779012020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3254ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20240127_f3e6b1ad-810b-4f53-b92a-b28fc2111f3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNf3e6b1ad-810b-4f53-b92a-b28fc2111f3f8
197311acyclovir 400 MG Oral TabletSCDf3e6b1ad-810b-4f53-b92a-b28fc2111f3f8
197311acycycloguanosine 400 MG Oral TabletSYf3e6b1ad-810b-4f53-b92a-b28fc2111f3f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3254-05009032540090 TABLET in 1 BOTTLE (50090-3254-0) 90 tablet2017-11-170000-00-00NoNoCurrent
50090-3254-15009032540121 TABLET in 1 BOTTLE (50090-3254-1) 21 tablet2017-11-090000-00-00NoNoCurrent