Home NDC 65862-073 Abacavir
Product NDC 65862-073
11-digit product format 658620073
Labeler code 65862
Product ID 65862-073_6aae2ecb-8c31-48c8-9e6d-6b41c5ab4da4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077844
Marketing category ANDA
Marketing start 2012-12-17
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 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-073 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 65862-073 65862-073-18 UNFINISHED Active or certified unfinished drug listing 2026-08-03
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 · 42 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 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-073-18 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-073-18 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-073-18 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-073-18 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-073-18 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-073-18 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-073-18 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-073-18 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-073-18 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-073-18 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-073-18 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-073-18 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-073-18 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-073-18 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 65862-073-18 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 65862-073-18 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 65862-073-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 65862-073-18 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 65862-073-18 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 65862-073-18 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 65862-073-18 5b2001dcd8f5…54b53d4dc9e4…
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 A077844-001 ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077844-001 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 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077844-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-12-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Abacavir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABACAVIR SULFATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J220T4J9Q2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242679 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-073-60 Abacavir 60 in 1 BOTTLE TABLET, FILM COATED 60 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 ABACAVIR ACTIVE MOIETY WR2TIP26VS ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 ABACAVIR ACTIVE MOIETY WR2TIP26VS ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-073 ABACAVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 16 Current NDC, Legacy NDC, 1 package rows 20240507_5409c8ed-17c3-454f-bb88-d597ba8f84ec.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65862-073-18 65862007318 1800 TABLET, FILM COATED in 1 BAG (65862-073-18) 17-DEC-12 Current 65862-073-60 65862007360 60 TABLET, FILM COATED in 1 BOTTLE (65862-073-60) 2012-12-17 0000-00-00 No No Current