FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
61919-654
11-digit product format
619190654
Labeler code
61919
Product ID
61919-654_879d96b3-0ad3-4927-9a4d-bc0908d2d387
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA203834
Marketing category
ANDA
Marketing start
2015-01-01
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
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
61919-654-142025-01-30C16284748780-12cef2736-9de8-d83d-e063-dadaa90ab31fAcyclovir
61919-654-302020-01-31C16284748780-19d75b9d1-2982-f424-e053-dadaa90a57ceACYCLOVIR
61919-654-402020-01-31C16284748780-19d75b9d1-2982-f424-e053-dadaa90a57ceACYCLOVIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-654-30ACYCLOVIR30 in 1 BOTTLETABLET302
61919-654-40ACYCLOVIR40 in 1 BOTTLETABLET402
61919-654-14Acyclovir14 in 1 BOTTLETABLET141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-654-14EA - Each61919-6544ebc474a-45f6-48c9-931b-d0c78bfd2a3412023-10-16
61919-654-30EA - Each61919-654d320fa9f-f9e6-489c-8676-3ee11972b5f812016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [DIRECTRX]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [DIRECTRX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [DIRECTRX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [DIRECTRX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACYCLOVIR TABLET [DIRECTRX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [DIRECTRX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EACYCLOVIR TABLET [DIRECTRX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [DIRECTRX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-654ACYCLOVIR TABLET [DIRECTRX]2Legacy NDC, 2 package rows20151105_96fcc438-fc47-456c-bf31-6df278b12244.zip
61919-654ACYCLOVIR TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20230912_0514f788-1b06-9239-e063-6294a90a8ac2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN96fcc438-fc47-456c-bf31-6df278b122442
197311acyclovir 400 MG Oral TabletSCD96fcc438-fc47-456c-bf31-6df278b122442
197311acycycloguanosine 400 MG Oral TabletSY96fcc438-fc47-456c-bf31-6df278b122442
197311acyclovir 400 MG Oral TabletPSN0514f788-1b06-9239-e063-6294a90a8ac21
197311acyclovir 400 MG Oral TabletSCD0514f788-1b06-9239-e063-6294a90a8ac21
197311acycycloguanosine 400 MG Oral TabletSY0514f788-1b06-9239-e063-6294a90a8ac21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-654-146191906541414 in 1 BOTTLEHistorical
61919-654-306191906543030 in 1 BOTTLEHistorical
61919-654-406191906544040 in 1 BOTTLEHistorical