FDA.reportPublic FDA data

Acyclovir

Product NDC
50090-6335
11-digit product format
500906335
Labeler code
50090
Product ID
50090-6335_d3a10247-e6a9-4247-b1cc-87092d2b6033
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209366
Marketing category
ANDA
Marketing start
2020-08-15
Substance
ACYCLOVIR
Active strength
800 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
ACYCLOVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197313

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6335-0Acyclovir35 in 1 BOTTLETABLET354
50090-6335-2Acyclovir70 in 1 BOTTLETABLET704
50090-6335-3Acyclovir40 in 1 BOTTLETABLET404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6335-0EA - Each50090-6335fe805ef1-d3be-451d-81cd-e5bf39c0948912023-03-13
50090-6335-2EA - Each50090-6335f12a8b51-3943-4860-9f3e-279d83dddefd12023-03-13
50090-6335-3EA - Each50090-633531cf942a-d3ed-4f0a-a477-76709bb7d9b112023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6335ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 3 package rows20230208_34a38cdf-04e8-4006-a9f5-4a0831117d61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN34a38cdf-04e8-4006-a9f5-4a0831117d614
197313acyclovir 800 MG Oral TabletSCD34a38cdf-04e8-4006-a9f5-4a0831117d614
197313acycycloguanosine 800 MG Oral TabletSY34a38cdf-04e8-4006-a9f5-4a0831117d614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6335-05009063350035 TABLET in 1 BOTTLE (50090-6335-0) 35 tablet2023-01-18NoNoCurrent
50090-6335-25009063350270 TABLET in 1 BOTTLE (50090-6335-2) 70 tablet2023-01-18NoNoCurrent
50090-6335-35009063350340 TABLET in 1 BOTTLE (50090-6335-3) 40 tablet2023-01-18NoNoCurrent