FDA.reportPublic FDA data

Acyclovir

Product NDC
63304-504
11-digit product format
633040504
Labeler code
63304
Product ID
63304-504_7a18c7e7-b635-439a-8f8b-8dac5704fba6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Ranbaxy Laboratories Ltd.
Application
ANDA074980
Marketing category
ANDA
Marketing start
1999-02-08
Marketing end
0000-00-00
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
63304-504-012020-01-31C16284748780-19d75b9d0-afde-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES, USP AND ACYCLOVIR TABLETS, USP Rx only
63304-504-282020-01-31C16284748780-19d75b9d0-afde-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES, USP AND ACYCLOVIR TABLETS, USP Rx only
63304-504-502020-01-31C16284748780-19d75b9d0-afde-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES, USP AND ACYCLOVIR TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-504-01Acyclovir100 in 1 BOTTLETABLET1005
63304-504-28Acyclovir180 in 1 BOTTLETABLET1805
63304-504-50Acyclovir50 in 1 BOTTLETABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-504-01EA - Each63304-504d567bd49-1a51-412a-8fe4-a475809d62e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [REDPHARM DRUG INC.]5
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
AcyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [REDPHARM DRUG INC.]5
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [REDPHARM DRUG INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [REDPHARM DRUG INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [STAT RX USA]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [STAT RX USA]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [STAT RX USA]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [STAT RX USA]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [STAT RX USA]2
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
acyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-504ACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5Legacy NDC, 3 package rows20130930_d13b8cdd-59fd-472b-8125-a19f42ef5402.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNd13b8cdd-59fd-472b-8125-a19f42ef54025
197311acyclovir 400 MG Oral TabletPSNffa99978-6b66-49ab-9bd2-8ef6f6846cd75
197311acyclovir 400 MG Oral TabletPSNd13b8cdd-59fd-472b-8125-a19f42ef54025
197313acyclovir 800 MG Oral TabletPSNd13b8cdd-59fd-472b-8125-a19f42ef54025
197310acyclovir 200 MG Oral CapsuleSCDd13b8cdd-59fd-472b-8125-a19f42ef54025
197311acyclovir 400 MG Oral TabletSCDffa99978-6b66-49ab-9bd2-8ef6f6846cd75
197311acyclovir 400 MG Oral TabletSCDd13b8cdd-59fd-472b-8125-a19f42ef54025
197313acyclovir 800 MG Oral TabletSCDd13b8cdd-59fd-472b-8125-a19f42ef54025
197310acycycloguanosine 200 MG Oral CapsuleSYd13b8cdd-59fd-472b-8125-a19f42ef54025
197311acycycloguanosine 400 MG Oral TabletSYffa99978-6b66-49ab-9bd2-8ef6f6846cd75
197311acycycloguanosine 400 MG Oral TabletSYd13b8cdd-59fd-472b-8125-a19f42ef54025
197313acycycloguanosine 800 MG Oral TabletSYd13b8cdd-59fd-472b-8125-a19f42ef54025
197311acyclovir 400 MG Oral TabletPSN3b80d222-4d88-4ddd-afbf-8f316e9463d52
197313acyclovir 800 MG Oral TabletPSN3b80d222-4d88-4ddd-afbf-8f316e9463d52
197311acyclovir 400 MG Oral TabletSCD3b80d222-4d88-4ddd-afbf-8f316e9463d52
197313acyclovir 800 MG Oral TabletSCD3b80d222-4d88-4ddd-afbf-8f316e9463d52
197311acycycloguanosine 400 MG Oral TabletSY3b80d222-4d88-4ddd-afbf-8f316e9463d52
197313acycycloguanosine 800 MG Oral TabletSY3b80d222-4d88-4ddd-afbf-8f316e9463d52
197310acyclovir 200 MG Oral CapsulePSNa2db7131-bf31-47bf-bf61-594f919af1f21
197310acyclovir 200 MG Oral CapsulePSNf41aa20a-8824-477e-8f04-69760ba1197e1
197311acyclovir 400 MG Oral TabletPSNa2db7131-bf31-47bf-bf61-594f919af1f21
197311acyclovir 400 MG Oral TabletPSNf41aa20a-8824-477e-8f04-69760ba1197e1
197313acyclovir 800 MG Oral TabletPSNa2db7131-bf31-47bf-bf61-594f919af1f21
197310acyclovir 200 MG Oral CapsuleSCDf41aa20a-8824-477e-8f04-69760ba1197e1
197310acyclovir 200 MG Oral CapsuleSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197311acyclovir 400 MG Oral TabletSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197311acyclovir 400 MG Oral TabletSCDf41aa20a-8824-477e-8f04-69760ba1197e1
197313acyclovir 800 MG Oral TabletSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197310acycycloguanosine 200 MG Oral CapsuleSYf41aa20a-8824-477e-8f04-69760ba1197e1
197310acycycloguanosine 200 MG Oral CapsuleSYa2db7131-bf31-47bf-bf61-594f919af1f21
197311acycycloguanosine 400 MG Oral TabletSYa2db7131-bf31-47bf-bf61-594f919af1f21
197311acycycloguanosine 400 MG Oral TabletSYf41aa20a-8824-477e-8f04-69760ba1197e1
197313acycycloguanosine 800 MG Oral TabletSYa2db7131-bf31-47bf-bf61-594f919af1f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-504-0163304050401100 in 1 BOTTLEHistorical
63304-504-2863304050428180 in 1 BOTTLEHistorical
63304-504-506330405045050 in 1 BOTTLEHistorical