FDA.reportPublic FDA data

Acyclovir

Product NDC
51655-679
11-digit product format
516550679
Labeler code
51655
Product ID
51655-679_494f95a1-acbf-b84c-e063-6294a90af7af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA203834
Marketing category
ANDA
Marketing start
2023-02-15
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
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
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
51655-679-35Acyclovir35 in 1 BOTTLE, PLASTICTABLET353
51655-679-51Acyclovir40 in 1 BOTTLE, PLASTICTABLET403
51655-679-52Acyclovir30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-679ACYCLOVIR TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 3 package rows20230630_f6f56143-ea74-af87-e053-6394a90ae346.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNf6f56143-ea74-af87-e053-6394a90ae3463
197313acyclovir 800 MG Oral TabletSCDf6f56143-ea74-af87-e053-6394a90ae3463
197313acycycloguanosine 800 MG Oral TabletSYf6f56143-ea74-af87-e053-6394a90ae3463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-679-355165506793535 TABLET in 1 BOTTLE, PLASTIC (51655-679-35) 35 tablet2023-03-02NoNoCurrent
51655-679-515165506795140 TABLET in 1 BOTTLE, PLASTIC (51655-679-51) 40 tablet2023-02-15NoNoCurrent
51655-679-525165506795230 TABLET in 1 BOTTLE, PLASTIC (51655-679-52) 30 tablet2023-06-02NoNoCurrent