FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
67296-0375
11-digit product format
672960375
Labeler code
67296
Product ID
67296-0375_75712ad2-36fe-4a9d-a722-970e4e594bec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA074596
Marketing category
ANDA
Marketing start
2009-04-01
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
67296-0375-12020-01-31C16284748780-19d75b9d0-8827-f424-e053-dadaa90a57ceAcyclovir tablets
67296-0375-22020-01-31C16284748780-19d75b9d0-8827-f424-e053-dadaa90a57ceAcyclovir tablets
67296-0375-32020-01-31C16284748780-19d75b9d0-8827-f424-e053-dadaa90a57ceAcyclovir tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0375-1ACYCLOVIR20 in 1 BOTTLETABLET205
67296-0375-2ACYCLOVIR30 in 1 BOTTLETABLET305
67296-0375-3ACYCLOVIR70 in 1 BOTTLETABLET705

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [REDPHARM DRUG INC.]5
AcyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [REDPHARM DRUG INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [REDPHARM DRUG INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [REDPHARM DRUG INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [REDPHARM DRUG INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0375ACYCLOVIR TABLET [REDPHARM DRUG INC.]5Legacy NDC, 3 package rows20110808_ffa99978-6b66-49ab-9bd2-8ef6f6846cd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNffa99978-6b66-49ab-9bd2-8ef6f6846cd75
197311acyclovir 400 MG Oral TabletSCDffa99978-6b66-49ab-9bd2-8ef6f6846cd75
197311acycycloguanosine 400 MG Oral TabletSYffa99978-6b66-49ab-9bd2-8ef6f6846cd75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0375-16729603750120 in 1 BOTTLEHistorical
67296-0375-26729603750230 in 1 BOTTLEHistorical
67296-0375-36729603750370 in 1 BOTTLEHistorical