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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71403-049IInactivated by FDA2026-08-03
excluded packagepackage71403-04971403-049-02IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71403-049-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71403-049-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71403-049-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71403-049-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71403-049-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71403-049-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71403-049-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71403-049-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71403-049-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71403-049-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71403-049-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71403-049-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71403-049-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71403-049-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71403-049-021332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203791-001SITAVIGACYCLOVIR50MGTABLET / BUCCALRLD2013-04-12

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203791-00187911272027-03-23U-1460Drug product2014-08-06
N203791-00187478962027-06-03U-1460Drug product2014-07-03
N203791-00185924342030-06-16U-1460Drug product2013-12-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203791-001SITAVIG50MGTABLET / BUCCALRLD2013-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203791-001SITAVIG50MGTABLET / BUCCALRLD2013-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N203791-001SITAVIG50MGTABLET / BUCCALRLD2013-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-123f01610625f2…
2019-09-15 20:21 UTC2019-09N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N203791-001SITAVIG50MGTABLET / BUCCALRLD, RS2013-04-12cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203791-00187911272027-03-23U-1460Drug product2014-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203791-00187478962027-06-03U-1460Drug product2014-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203791-00185924342030-06-16U-1460Drug product2013-12-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203791-00187911272027-03-23U-1460Drug product2014-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203791-00187478962027-06-03U-1460Drug product2014-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203791-00185924342030-06-16U-1460Drug product2013-12-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N203791-00187911272027-03-23U-1460Drug product2014-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203791-00187478962027-06-03U-1460Drug product2014-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203791-00185924342030-06-16U-1460Drug product2013-12-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203791-00187911272027-03-23U-1460Drug product2014-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203791-00187478962027-06-03U-1460Drug product2014-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203791-00185924342030-06-16U-1460Drug product2013-12-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203791-00187911272027-03-23U-1460Drug product2014-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203791-00187478962027-06-03U-1460Drug product2014-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203791-00185924342030-06-16U-1460Drug product2013-12-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203791-00187911272027-03-23U-1460Drug product2014-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203791-00187478962027-06-03U-1460Drug product2014-07-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203791-00185924342030-06-16U-1460Drug product2013-12-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203791-00187911272027-03-23U-1460Drug product2014-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203791-00187478962027-06-03U-1460Drug product2014-07-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203791-00185924342030-06-16U-1460Drug product2013-12-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203791-00187911272027-03-23U-1460Drug product2014-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203791-00187478962027-06-03U-1460Drug product2014-07-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203791-00185924342030-06-16U-1460Drug product2013-12-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203791-00187911272027-03-23U-1460Drug product2014-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203791-00187478962027-06-03U-1460Drug product2014-07-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203791-00185924342030-06-16U-1460Drug product2013-12-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203791-00187911272027-03-23U-1460Drug product2014-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N203791-00187478962027-06-03U-1460Drug product2014-07-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N203791-00185924342030-06-16U-1460Drug product2013-12-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203791-00187911272027-03-23U-1460Drug product2014-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203791-00187478962027-06-03U-1460Drug product2014-07-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203791-00185924342030-06-16U-1460Drug product2013-12-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203791-00187911272027-03-23U-1460Drug product2014-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203791-00187478962027-06-03U-1460Drug product2014-07-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203791-00185924342030-06-16U-1460Drug product2013-12-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203791-00187911272027-03-23U-1460Drug product2014-08-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203791-00187478962027-06-03U-1460Drug product2014-07-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203791-00185924342030-06-16U-1460Drug product2013-12-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203791-00187911272027-03-23U-1460Drug product2014-08-068072bd15b7f6…

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
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