FDA.reportPublic FDA data

Acyclovir

Product NDC
50090-7276
11-digit product format
500907276
Labeler code
50090
Product ID
50090-7276_3b5b02bb-78f9-4147-923c-23c5e3170132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210401
Marketing category
ANDA
Marketing start
2023-06-20
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7276-0Acyclovir90 in 1 BOTTLETABLET903
50090-7276-1Acyclovir21 in 1 BOTTLETABLET213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7276-0EA - Each50090-7276d6da1847-493e-4267-b194-80a528bc79bb12024-11-05
50090-7276-1EA - Each50090-7276c7c8da91-03d8-473b-bdfc-1b6ea23c441f12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7276ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20241015_b96e44ca-aa54-4a64-89f4-fb5a5932ceae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNb96e44ca-aa54-4a64-89f4-fb5a5932ceae3
197311acyclovir 400 MG Oral TabletSCDb96e44ca-aa54-4a64-89f4-fb5a5932ceae3
197311acycycloguanosine 400 MG Oral TabletSYb96e44ca-aa54-4a64-89f4-fb5a5932ceae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7276-05009072760090 TABLET in 1 BOTTLE (50090-7276-0) 90 tablet2024-10-08NoNoCurrent
50090-7276-15009072760121 TABLET in 1 BOTTLE (50090-7276-1) 21 tablet2024-10-08NoNoCurrent