FDA.reportPublic FDA data

Acyclovir

Product NDC
60760-778
11-digit product format
607600778
Labeler code
60760
Product ID
60760-778_1493e22d-455e-b613-e063-6294a90afede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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
60760-778-35Acyclovir35 in 1 BOTTLE, PLASTICTABLET351

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-778-35EA - Each60760-778dc575875-77a6-49ab-88e9-42f7527a989212024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-778ACYCLOVIR TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20240328_1493e22d-455d-b613-e063-6294a90afede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN1493e22d-455d-b613-e063-6294a90afede1
197313acyclovir 800 MG Oral TabletSCD1493e22d-455d-b613-e063-6294a90afede1
197313acycycloguanosine 800 MG Oral TabletSY1493e22d-455d-b613-e063-6294a90afede1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-778-356076007783535 TABLET in 1 BOTTLE, PLASTIC (60760-778-35) 35 tablet2024-03-15NoNoCurrent