Home NDC 53808-0767 EPZICOM
Product NDC 53808-0767
11-digit product format 538080767
Labeler code 53808
Product ID 53808-0767_74505e7d-79df-4432-83b4-dc03d441e0cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate and lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application NDA021652
Marketing category NDA
Marketing start 2009-07-01
Marketing end 0000-00-00
Substance ABACAVIR SULFATE; LAMIVUDINE
Active strength 600 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]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 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 53808-0767-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0767-1 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 N021652-001 EPZICOM ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02
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 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL RLD 2004-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL RLD 2004-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL RLD 2004-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL RLD 2004-08-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL RLD 2004-08-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL RLD 2004-08-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021652-001 EPZICOM EQ 600MG BASE;300MG TABLET / ORAL AB RLD, RS 2004-08-02 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 53808-0767-1 EPZICOM 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 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 ABACAVIR ACTIVE MOIETY WR2TIP26VS EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) 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 53808-0767 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 Legacy NDC, 1 package rows 20100809_e0fc8605-1d64-41ab-af7e-bcf66a57c1fd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0767-1 53808076701 30 in 1 BLISTER PACK Historical