FDA.reportPublic FDA data

Acyclovir

Product NDC
51655-300
11-digit product format
516550300
Labeler code
51655
Product ID
51655-300_48eadee3-c054-1e41-e063-6294a90a6a66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA203834
Marketing category
ANDA
Marketing start
2014-10-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2027-12-31

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
51655-300-232023-02-27C16284748780-19d75b9d0-a0c9-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
51655-300-252023-02-27C16284748780-19d75b9d0-a0c9-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
51655-300-522023-02-27C16284748780-19d75b9d0-a0c9-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
51655-300-232020-01-31C16284748780-19d75b9d0-a0c9-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
51655-300-252020-01-31C16284748780-19d75b9d0-a0c9-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
51655-300-522020-01-31C16284748780-19d75b9d0-a0c9-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-300-23Acyclovir25 in 1 BOTTLE, DISPENSINGTABLET257
51655-300-26Acyclovir90 in 1 BOTTLE, PLASTICTABLET907
51655-300-35Acyclovir35 in 1 BOTTLE, PLASTICTABLET357
51655-300-50Acyclovir60 in 1 BOTTLE, PLASTICTABLET607
51655-300-52Acyclovir30 in 1 BOTTLE, DISPENSINGTABLET307
51655-300-54Acyclovir15 in 1 BOTTLE, PLASTICTABLET157
51655-300-84Acyclovir14 in 1 BOTTLE, PLASTICTABLET147

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [NORTHWIND PHARMACEUTICALS, LLC]3
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [NORTHWIND PHARMACEUTICALS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-300ACYCLOVIR TABLET [NORTHWIND PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 7 package rows20240110_5dcfd21c-43f0-469c-be70-a4e74e6ccf88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN5dcfd21c-43f0-469c-be70-a4e74e6ccf887
197311acyclovir 400 MG Oral TabletSCD5dcfd21c-43f0-469c-be70-a4e74e6ccf887
197311acycycloguanosine 400 MG Oral TabletSY5dcfd21c-43f0-469c-be70-a4e74e6ccf887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-300-235165503002325 TABLET in 1 BOTTLE, DISPENSING (51655-300-23) 25 tablet2023-12-05NoNoCurrent
51655-300-265165503002690 TABLET in 1 BOTTLE, PLASTIC (51655-300-26) 90 tablet2023-05-05NoNoCurrent
51655-300-355165503003535 TABLET in 1 BOTTLE, PLASTIC (51655-300-35) 35 tablet2022-12-02NoNoCurrent
51655-300-505165503005060 TABLET in 1 BOTTLE, PLASTIC (51655-300-50) 60 tablet2022-12-02NoNoCurrent
51655-300-525165503005230 TABLET in 1 BOTTLE, DISPENSING (51655-300-52) 30 tablet2014-10-22NoNoCurrent
51655-300-545165503005415 TABLET in 1 BOTTLE, PLASTIC (51655-300-54) 15 tablet2023-01-11NoNoCurrent
51655-300-845165503008414 TABLET in 1 BOTTLE, PLASTIC (51655-300-84) 14 tablet2023-01-25NoNoCurrent