Home NDC 70518-1274 Abacavir
Product NDC 70518-1274
11-digit product format 705181274
Labeler code 70518
Product ID 70518-1274_f05a16e4-0e69-224c-e053-2a95a90a90e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA078119
Marketing category ANDA
Marketing start 2018-06-21
Marketing end 0000-00-00
Substance ABACAVIR SULFATE
Active strength 300 mg/1
Pharmacologic classes Cytochrome P450 1A1 Inhibitors [MoA], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], 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 · 4 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 70518-1274-0 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 70518-1274-0 f5e01cc5f278…a2eaf40c39c3…
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 A078119-001 ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078119-001 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 · 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 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Abacavir ABACAVIR Cipla USA Inc. 0d791375-e311-41f9-87b8-940657e6318c 2020-12-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078119 application number: ANDA078119
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-1274-0 70518127400 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1274-0) 2018-06-21 0000-00-00 No No Current