Home NDC 53808-0811 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 Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 34 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-03-10 12:48 UTC · source 2025-03-10 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 53808-0811 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0811 53808-0811-1 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020977-001 ZIAGEN ABACAVIR SULFATE EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-17
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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020977-001 ZIAGEN EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020977-001 ZIAGEN EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020977-001 ZIAGEN EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020977-001 ZIAGEN EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020977-001 ZIAGEN EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020977-001 ZIAGEN EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL RLD 1998-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020977-001 ZIAGEN EQ 300MG BASE TABLET / ORAL AB RLD, RS 1998-12-17 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-0811-1 ZIAGEN 1 in 1 BLISTER PACK TABLET, FILM COATED 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ABACAVIR ACTIVE MOIETY WR2TIP26VS ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0811 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20100526_ff62bcaa-a200-4ebf-a9ca-1ab2c254751c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0811-1 53808081101 1 in 1 BLISTER PACK Historical