FDA.reportPublic FDA data

Acyclovir

Product NDC
50268-061
11-digit product format
502680061
Labeler code
50268
Product ID
50268-061_47e22393-03a9-791e-e063-6294a90aa89a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075382
Marketing category
ANDA
Marketing start
2011-03-16
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, 197313

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
50268-061-11Acyclovir1 in 1 BLISTER PACKTABLET116
50268-061-15Acyclovir50 in 1 BOTTLE, UNIT-DOSETABLET5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-061-11EA - Each50268-061ecf90e4e-1ad7-4f49-9b27-670b998f548412015-04-03
50268-061-15EA - Each50268-0617fc1697a-9723-45b1-8320-d4db7f884ce512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
Starch, CornINACTIVE INGREDIENTO8232NY3SJACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [CARDINAL HEALTH]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [CARDINAL HEALTH]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [CARDINAL HEALTH]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [CARDINAL HEALTH]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-061ACYCLOVIR TABLET [AVPAK]15Current NDC, Legacy NDC, 2 package rows20231018_6e203fa9-ee97-1e08-8d6a-fb57cfa13e19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acyclovir 400 MG Oral TabletPSNd8004652-86fe-4714-81d4-5e1dd2585bb416
197313acyclovir 800 MG Oral TabletPSN6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acyclovir 400 MG Oral TabletSCD6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acyclovir 400 MG Oral TabletSCDd8004652-86fe-4714-81d4-5e1dd2585bb416
197313acyclovir 800 MG Oral TabletSCD6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acycycloguanosine 400 MG Oral TabletSY6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acycycloguanosine 400 MG Oral TabletSYd8004652-86fe-4714-81d4-5e1dd2585bb416
197313acycycloguanosine 800 MG Oral TabletSY6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-061-11502680061111 in 1 BLISTER PACKHistorical
50268-061-155026800611550 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (50268-061-15) / 1 TABLET in 1 BLISTER PACK (50268-061-11) 50 blister pack2011-03-160000-00-00NoNoCurrent