Home NDC 35573-430-30 Abacavir and Lamivudine
Product NDC 35573-430
Requested package NDC 35573-430-30
11-digit product format 355730430
Labeler code 35573
Product ID 35573-430_307f2ff8-c695-482a-88af-52a48e65c01b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir and Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA090159
Marketing category ANDA
Marketing start 2019-11-15
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 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090159-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090159-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2018-11-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35573-430-30 35573043030 1 BOTTLE in 1 CARTON (35573-430-30) > 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2019-11-15 0000-00-00 No No Current