FDA.reportPublic FDA data

Acyclovir

Product NDC
42254-198
11-digit product format
422540198
Labeler code
42254
Product ID
42254-198_ec3d8135-2892-4186-ac31-c7deadd0b975
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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
2017-12-31
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
42254-198-212019-09-24C16284748780-19350213a-3dac-c013-e053-90daa90a1393Acyclovir
42254-198-252019-09-24C16284748780-19350213a-3dac-c013-e053-90daa90a1393Acyclovir
42254-198-302019-09-24C16284748780-19350213a-3dac-c013-e053-90daa90a1393Acyclovir
42254-198-352019-09-24C16284748780-19350213a-3dac-c013-e053-90daa90a1393Acyclovir
42254-198-502019-09-24C16284748780-19350213a-3dac-c013-e053-90daa90a1393Acyclovir

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-198-21Acyclovir21 in 1 BOTTLETABLET213
42254-198-25Acyclovir25 in 1 BOTTLETABLET253
42254-198-30Acyclovir30 in 1 BOTTLETABLET303
42254-198-35Acyclovir35 in 1 BOTTLETABLET353
42254-198-50Acyclovir50 in 1 BOTTLETABLET503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-198-21EA - Each42254-19818cd57e5-6fbc-4ffa-ab11-e40ee058065012013-02-19
42254-198-25EA - Each42254-198fa295944-bb21-49bf-956d-9ad5e0bd87f012013-02-19
42254-198-30EA - Each42254-198be795e37-9fc7-443a-8cae-483ab03a1da612013-04-01
42254-198-35EA - Each42254-19831cdcf90-6771-4d24-9b1d-e4cd5361acd712012-07-24
42254-198-50EA - Each42254-1986cbdfcea-11f9-422d-81a8-d79a36027f4212013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
acyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
magnesium stearateINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-198ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3Legacy NDC, 5 package rows20130329_bf1e7864-07c5-4c2c-a075-fad00612ee2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197313acyclovir 800 MG Oral TabletPSNbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197311acyclovir 400 MG Oral TabletSCDbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197313acyclovir 800 MG Oral TabletSCDbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197311acycycloguanosine 400 MG Oral TabletSYbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197313acycycloguanosine 800 MG Oral TabletSYbf1e7864-07c5-4c2c-a075-fad00612ee2a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-198-214225401982121 in 1 BOTTLEHistorical
42254-198-254225401982525 in 1 BOTTLEHistorical
42254-198-304225401983030 in 1 BOTTLEHistorical
42254-198-354225401983535 in 1 BOTTLEHistorical
42254-198-504225401985050 in 1 BOTTLEHistorical