ZIAGEN

Product NDC
53808-0811
11-digit product format
538080811
Labeler code
53808
Product ID
53808-0811_dd74d4f9-ed20-47b0-bb3d-4a8ad228a21e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abacavir sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020977
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
ABACAVIR SULFATE
Active strength
300 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct53808-0811IInactivated by FDA2026-09-14
excluded packagepackage53808-081153808-0811-1IInactivated by FDA2026-09-14

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 · 44 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 packagepackage53808-0811-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0811-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0811-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0811-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0811-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0811-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0811-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0811-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0811-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0811-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0811-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0811-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0811-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0811-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0811-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0811-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0811-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0811-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0811-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0811-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0811-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0811-1110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020977-001ZIAGENABACAVIR SULFATEEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-17

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020977-001ZIAGENEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-1784e616aacf4f…
2026-08-18 06:07:402026-07N020977-001ZIAGENEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020977-001ZIAGENEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020977-001ZIAGENEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020977-001ZIAGENEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020977-001ZIAGENEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020977-001ZIAGENEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020977-001ZIAGENEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-173f01610625f2…
2019-09-15 20:21 UTC2019-09N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020977-001ZIAGENEQ 300MG BASETABLET / ORALRLD1998-12-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020977-001ZIAGENEQ 300MG BASETABLET / ORALABRLD, RS1998-12-17f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020977-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020977-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020977-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020977-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020977-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020977-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020977-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020977-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020977-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020977-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020977-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020977-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020977-001AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12N020977-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020977-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020977-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020977-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020977-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020977-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020977-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020977-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020977-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020977-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020977-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aaa99659-c62c-7281-d402-9590409850c2Product name620260128
3832141c-c294-474a-9473-1052c891450eProduct name220230105
e1e3cf65-28b8-ebf3-c11f-d11a82e0862aProduct name420180604
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0811-1ZIAGEN1 in 1 BLISTER PACKTABLET, FILM COATED11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ABACAVIRACTIVE MOIETYWR2TIP26VSZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0811ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100526_ff62bcaa-a200-4ebf-a9ca-1ab2c254751c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242679abacavir 300 MG Oral TabletPSNff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
213460Ziagen 300 MG Oral TabletPSNff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
213460abacavir 300 MG Oral Tablet [Ziagen]SBDff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
242679abacavir 300 MG Oral TabletSCDff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSYff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
213460Ziagen 300 MG Oral TabletSYff62bcaa-a200-4ebf-a9ca-1ab2c254751c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0811-1538080811011 in 1 BLISTER PACKHistorical