Home NDC 53808-0990 TRIZIVIR
Product NDC 53808-0990
11-digit product format 538080990
Labeler code 53808
Product ID 53808-0990_a6299f1c-1ddb-4da4-a38d-2cb34eca0c02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate, lamivudine, and zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application NDA021205
Marketing category NDA
Marketing start 2013-02-01
Marketing end 0000-00-00
Substance ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
Active strength 300 mg/1; mg/1; mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],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# 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0990-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0990-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0990-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0990-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0990-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0990-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0990-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0990-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0990-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0990-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0990-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0990-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0990-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0990-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0990-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0990-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0990-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0990-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0990-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0990-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0990-1 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 N021205-001 TRIZIVIR ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-11-14
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 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL RLD 2000-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021205-001 TRIZIVIR EQ 300MG BASE;150MG;300MG TABLET / ORAL AB RLD, RS 2000-11-14 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 53808-0990-1 TRIZIVIR 30 in 1 BLISTER PACK TABLET, FILM COATED 30 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 ABACAVIR ACTIVE MOIETY WR2TIP26VS TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0990 TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 Legacy NDC, 1 package rows 20140428_3354e50f-4dc5-413f-b5ae-87353ab8913d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0990-1 53808099001 30 in 1 BLISTER PACK Historical