FDA.reportPublic FDA data

Acyclovir

Product NDC
50090-7275
11-digit product format
500907275
Labeler code
50090
Product ID
50090-7275_810fa4f4-8281-44c0-98c2-a3cc70098fab
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
50090-7275-2Acyclovir25 in 1 BOTTLETABLET251
50090-7275-3Acyclovir50 in 1 BOTTLETABLET501
50090-7275-4Acyclovir15 in 1 BOTTLETABLET151
50090-7275-5Acyclovir30 in 1 BOTTLETABLET301
50090-7275-6Acyclovir60 in 1 BOTTLETABLET601
50090-7275-9Acyclovir45 in 1 BOTTLETABLET451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7275-2EA - Each50090-72757a55394c-e34c-4224-b2f1-0c92443285ce12024-11-05
50090-7275-3EA - Each50090-7275c9a0260f-9723-4e32-837b-80145dbb4fb812024-11-05
50090-7275-4EA - Each50090-72756de32696-ae62-4e0b-ae23-bd0c3c3aea2412024-11-05
50090-7275-5EA - Each50090-7275c2f0126f-02d4-4115-9320-881e5d90d63212024-11-05
50090-7275-6EA - Each50090-72751ec8d1e1-52e5-4b9a-b5c2-1c7624c852de12024-11-05
50090-7275-9EA - Each50090-727537f1c892-69a5-4ae1-a485-cce83807d57112024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7275ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 6 package rows20241015_c0c29e0f-b6e2-49df-88d1-95b7b625d356.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNc0c29e0f-b6e2-49df-88d1-95b7b625d3561
197311acyclovir 400 MG Oral TabletSCDc0c29e0f-b6e2-49df-88d1-95b7b625d3561
197311acycycloguanosine 400 MG Oral TabletSYc0c29e0f-b6e2-49df-88d1-95b7b625d3561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7275-25009072750225 TABLET in 1 BOTTLE (50090-7275-2) 25 tablet2024-10-08NoNoCurrent
50090-7275-35009072750350 TABLET in 1 BOTTLE (50090-7275-3) 50 tablet2024-10-08NoNoCurrent
50090-7275-45009072750415 TABLET in 1 BOTTLE (50090-7275-4) 15 tablet2024-10-08NoNoCurrent
50090-7275-55009072750530 TABLET in 1 BOTTLE (50090-7275-5) 30 tablet2024-10-08NoNoCurrent
50090-7275-65009072750660 TABLET in 1 BOTTLE (50090-7275-6) 60 tablet2024-10-08NoNoCurrent
50090-7275-95009072750945 TABLET in 1 BOTTLE (50090-7275-9) 45 tablet2024-10-08NoNoCurrent