FDA.reportPublic FDA data

Sitavig

Product NDC
71403-049
11-digit product format
714030049
Labeler code
71403
Product ID
71403-049_7e36e856-cd1b-481d-bc96-846ac59b1548
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET, DELAYED RELEASE
Route
BUCCAL
Labeler
EPI Health, Inc
Application
NDA203791
Marketing category
NDA
Marketing start
2014-03-20
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
50 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
No
Listing certified through
2021-12-31
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
71403-049-022023-07-28C16284748780-10191ceaa-6596-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use SITAVIG safely and effectively. See full prescribing information for SITAVIG. SITAVIG (acyclovir) buccal tablets Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71403-049-02Sitavig1 in 1 CARTONTABLET, DELAYED RELEASE15
71403-049-02Sitavig2 in 1 BLISTER PACKTABLET, DELAYED RELEASE25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71403-049-01EA - Each71403-0498b11b469-76cf-47b5-96d3-7c7f2aedac2a12018-07-03
71403-049-02EA - Each71403-049baa8b603-1aa5-4294-a0b3-51088b7d0e0f12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71403-049SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [EPI HEALTH, INC]5Legacy NDC, 2 package rows20200612_cd6e902d-5753-49ec-bec8-b27176ed978e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1423662acyclovir 50 MG Buccal TabletPSNcd6e902d-5753-49ec-bec8-b27176ed978e5
1493276Sitavig 50 MG Buccal TabletPSNcd6e902d-5753-49ec-bec8-b27176ed978e5
1493276acyclovir 50 MG Buccal Tablet [Sitavig]SBDcd6e902d-5753-49ec-bec8-b27176ed978e5
1423662acyclovir 50 MG Buccal TabletSCDcd6e902d-5753-49ec-bec8-b27176ed978e5
1423662acycycloguanosine 50 MG Buccal TabletSYcd6e902d-5753-49ec-bec8-b27176ed978e5
1493276acycycloguanosine 50 MG Buccal Tablet [Sitavig]SYcd6e902d-5753-49ec-bec8-b27176ed978e5
1493276Sitavig 50 MG Buccal TabletSYcd6e902d-5753-49ec-bec8-b27176ed978e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71403-049-02714030049021 BLISTER PACK in 1 CARTON (71403-049-02) > 2 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2014-03-200000-00-00NoNoCurrent