Home NDC 53808-0627 Abacavir Sulfate
Product NDC 53808-0627
11-digit product format 538080627
Labeler code 53808
Product ID 53808-0627_61e9324f-3ef3-45d7-9735-a89a03aeec42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA091294
Marketing category ANDA
Marketing start 2013-01-01
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 No
Listing certified through 2019-12-31
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 · 32 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 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 53808-0627 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0627 53808-0627-1 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 A091294-001 ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091294-001 AB
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 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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 53808-0627-1 Abacavir Sulfate 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ABACAVIR ACTIVE MOIETY WR2TIP26VS ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP 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 53808-0627 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20140402_e3961e38-20d5-4014-a9d5-1ab13611abb9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0627-1 53808062701 30 in 1 BLISTER PACK Historical