Home NDC 66993-482 Abacavir and Lamivudine
Product NDC 66993-482
11-digit product format 669930482
Labeler code 66993
Product ID 66993-482_ee69959a-8c33-497b-a309-1c4a50a2b127
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate and lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Prasco Laboratories
Application NDA021652
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-09-29
Marketing end 2020-12-31
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 No
Listing certified through 0000-00-00
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 · 24 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 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 66993-482-30 557ba5c1ecfa…9c80585c8c6e…
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#