FDA.reportPublic FDA data

acyclovir

Product NDC
60505-5306
11-digit product format
605055306
Labeler code
60505
Product ID
60505-5306_99d0802e-98ae-2322-114d-9a06593c2dc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077309
Marketing category
ANDA
Marketing start
2007-06-09
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acyclovir

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
60505-5306-1acyclovir100 in 1 BOTTLETABLET1007
60505-5306-3acyclovir30 in 1 BOTTLETABLET307
60505-5306-5acyclovir500 in 1 BOTTLETABLET5007
60505-5306-8acyclovir1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-5306-1EA - Each60505-530663f2f8bd-5cf3-4d15-8377-3520d0fc587d12012-07-24
60505-5306-8EA - Each60505-530648317053-5167-4156-824f-60fc8e1781ed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [APOTEX CORP.]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [APOTEX CORP.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [APOTEX CORP.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACYCLOVIR TABLET [APOTEX CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [APOTEX CORP.]2
SILICON DIOXIDE, COLLOIDALINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [APOTEX CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-5306ACYCLOVIR TABLET [APOTEX CORP.]6Current NDC, Legacy NDC, 4 package rows20240425_7fdeb609-24c4-5024-52c3-6a32bc7f3fcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN499c6a98-0614-4ded-8526-909942bae8a419
197311acyclovir 400 MG Oral TabletSCD499c6a98-0614-4ded-8526-909942bae8a419
197311acycycloguanosine 400 MG Oral TabletSY499c6a98-0614-4ded-8526-909942bae8a419
197311acyclovir 400 MG Oral TabletPSN7fdeb609-24c4-5024-52c3-6a32bc7f3fcc7
197313acyclovir 800 MG Oral TabletPSN7fdeb609-24c4-5024-52c3-6a32bc7f3fcc7
197311acyclovir 400 MG Oral TabletSCD7fdeb609-24c4-5024-52c3-6a32bc7f3fcc7
197313acyclovir 800 MG Oral TabletSCD7fdeb609-24c4-5024-52c3-6a32bc7f3fcc7
197311acycycloguanosine 400 MG Oral TabletSY7fdeb609-24c4-5024-52c3-6a32bc7f3fcc7
197313acycycloguanosine 800 MG Oral TabletSY7fdeb609-24c4-5024-52c3-6a32bc7f3fcc7
197311acyclovir 400 MG Oral TabletPSNb2e8dafd-c9b6-ff73-e053-2995a90a16594
197311acyclovir 400 MG Oral TabletPSNb2ae0432-bd2a-1480-e053-2a95a90a6fc84
197311acyclovir 400 MG Oral TabletSCDb2e8dafd-c9b6-ff73-e053-2995a90a16594
197311acyclovir 400 MG Oral TabletSCDb2ae0432-bd2a-1480-e053-2a95a90a6fc84
197311acycycloguanosine 400 MG Oral TabletSYb2e8dafd-c9b6-ff73-e053-2995a90a16594
197311acycycloguanosine 400 MG Oral TabletSYb2ae0432-bd2a-1480-e053-2a95a90a6fc84
197311acyclovir 400 MG Oral TabletPSNd2cd1b6d-ba7a-478b-8b06-920c239f0e353
197311acyclovir 400 MG Oral TabletPSNada4004a-c10a-6190-e053-2a95a90a5e673
197311acyclovir 400 MG Oral TabletSCDada4004a-c10a-6190-e053-2a95a90a5e673
197311acyclovir 400 MG Oral TabletSCDd2cd1b6d-ba7a-478b-8b06-920c239f0e353
197311acycycloguanosine 400 MG Oral TabletSYada4004a-c10a-6190-e053-2a95a90a5e673
197311acycycloguanosine 400 MG Oral TabletSYd2cd1b6d-ba7a-478b-8b06-920c239f0e353
197311acyclovir 400 MG Oral TabletPSN95b0c656-f87c-8ba9-e053-2a95a90ae06c2
197311acyclovir 400 MG Oral TabletPSNd846dc43-d7d0-435a-8b61-c51b39c664aa2
197311acyclovir 400 MG Oral TabletSCD95b0c656-f87c-8ba9-e053-2a95a90ae06c2
197311acyclovir 400 MG Oral TabletSCDd846dc43-d7d0-435a-8b61-c51b39c664aa2
197311acycycloguanosine 400 MG Oral TabletSY95b0c656-f87c-8ba9-e053-2a95a90ae06c2
197311acycycloguanosine 400 MG Oral TabletSYd846dc43-d7d0-435a-8b61-c51b39c664aa2
197311acyclovir 400 MG Oral TabletPSN51052f0e-1a07-405a-a962-981ce9439e021
197311acyclovir 400 MG Oral TabletPSNe186fdc9-b60e-4280-8d60-36cae9f2838f1
197311acyclovir 400 MG Oral TabletSCD51052f0e-1a07-405a-a962-981ce9439e021
197311acyclovir 400 MG Oral TabletSCDe186fdc9-b60e-4280-8d60-36cae9f2838f1
197311acycycloguanosine 400 MG Oral TabletSY51052f0e-1a07-405a-a962-981ce9439e021
197311acycycloguanosine 400 MG Oral TabletSYe186fdc9-b60e-4280-8d60-36cae9f2838f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-5306-160505530601100 TABLET in 1 BOTTLE (60505-5306-1) 100 tablet2007-06-092026-12-31NoNoCurrent
60505-5306-36050553060330 TABLET in 1 BOTTLE (60505-5306-3) 30 tablet2007-06-090000-00-00NoNoCurrent
60505-5306-560505530605500 TABLET in 1 BOTTLE (60505-5306-5) 500 tablet2007-06-090000-00-00NoNoCurrent
60505-5306-8605055306081000 TABLET in 1 BOTTLE (60505-5306-8) 1000 tablet2007-06-090000-00-00NoNoCurrent