Home NDC 49702-206-13 EPZICOM
Product NDC 49702-206
Requested package NDC 49702-206-13
11-digit product format 497020206
Labeler code 49702
Product ID 49702-206_532f9480-523b-49ed-8df1-1aa4317706c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate and lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ViiV Healthcare Company
Application NDA021652
Marketing category NDA
Marketing start 2010-10-12
Marketing end 0000-00-00
Substance ABACAVIR SULFATE; LAMIVUDINE
Active strength 600 mg/1; mg/1
Pharmacologic classes Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record 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ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02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2026-02 N021652-001 EPZICOM EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021652-001 EPZICOM EQ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 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 [VIIV HEALTHCARE COMPANY] 15 LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 ABACAVIR ACTIVE MOIETY WR2TIP26VS EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-206 EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 29 Legacy NDC 20240615_f1139e7f-2db9-4961-9da3-9b7f2088736f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49702-206-13 49702020613 30 TABLET, FILM COATED in 1 BOTTLE (49702-206-13) 2010-10-12 0000-00-00 No No Current