Home NDC 68084-021 Abacavir
Product NDC 68084-021
11-digit product format 680840021
Labeler code 68084
Product ID 68084-021_1ea3a366-c7c0-2e89-e063-6294a90a2419
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA077844
Marketing category ANDA
Marketing start 2013-02-04
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 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 68084-021-11 Abacavir 1 in 1 BLISTER PACK TABLET, FILM COATED 1 7 68084-021-21 Abacavir 30 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 30 7
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 [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 68084-021 ABACAVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 7 Current NDC, Legacy NDC, 2 package rows 20240802_01e46f58-8bda-4ff3-ab21-57d5b540d440.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 Units Marketing start Marketing end Sample Exclude flag Status 68084-021-11 68084002111 1 in 1 BLISTER PACK Historical 68084-021-21 68084002121 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-021-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-021-11) 30 blister pack 2013-02-04 0000-00-00 No No Current