Acyclovir

Product NDC
63304-505
11-digit product format
633040505
Labeler code
63304
Product ID
63304-505_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
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-505-01Acyclovir100 in 1 BOTTLETABLET1005
63304-505-28Acyclovir180 in 1 BOTTLETABLET1805
63304-505-50Acyclovir50 in 1 BOTTLETABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-505-01EA - Each63304-5059d731f11-58b5-4dd7-96e7-341fe2e3c6b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]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 CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACYCLOVIR CAPSULE ACYCLOVIR TABLET [RANBAXY LABORATORIES LTD.]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
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
63304-505ACYCLOVIR 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 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 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 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
197311acyclovir 400 MG Oral TabletPSNa2db7131-bf31-47bf-bf61-594f919af1f21
197313acyclovir 800 MG Oral TabletPSNa2db7131-bf31-47bf-bf61-594f919af1f21
197310acyclovir 200 MG Oral CapsuleSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197311acyclovir 400 MG Oral TabletSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197313acyclovir 800 MG Oral TabletSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197310acycycloguanosine 200 MG Oral CapsuleSYa2db7131-bf31-47bf-bf61-594f919af1f21
197311acycycloguanosine 400 MG Oral TabletSYa2db7131-bf31-47bf-bf61-594f919af1f21
197313acycycloguanosine 800 MG Oral TabletSYa2db7131-bf31-47bf-bf61-594f919af1f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-505-0163304050501100 in 1 BOTTLEHistorical
63304-505-2863304050528180 in 1 BOTTLEHistorical
63304-505-506330405055050 in 1 BOTTLEHistorical