Home NDC 72865-167 Abacavir
Product NDC 72865-167
11-digit product format 728650167
Labeler code 72865
Product ID 72865-167_f26efe20-afb4-390a-e053-2a95a90ae396
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir
Dosage form TABLET
Route ORAL
Labeler XLCare Pharmaceuticals Inc.
Application ANDA091560
Marketing category ANDA
Marketing start 2021-05-28
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 A091560-001 ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091560-001 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 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2013-09-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Abacavir ABACAVIR Camber Pharmaceuticals, Inc. 44fb1e25-ad03-4a7f-9f35-2e29f5025661 2026-07-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091560 application number: ANDA091560 Abacavir ABACAVIR Coupler LLC 42ca758a-1694-c614-e063-6294a90a8c7e 2026-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091560 application number: ANDA091560 Abacavir ABACAVIR AvPAK a2f06528-f3c5-2466-e053-2995a90ae18a 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091560 application number: ANDA091560 Abacavir ABACAVIR XLCare Pharmaceuticals Inc. 633f1ec9-53b1-4a9a-a738-8cae5b763f08 2023-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091560 application number: ANDA091560 ndc (product): 72865-167
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 72865-167-60 Abacavir 60 in 1 BOTTLE TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72865-167 ABACAVIR (ABACAVIR) TABLET [XLCARE PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 1 package rows 20230117_633f1ec9-53b1-4a9a-a738-8cae5b763f08.zip
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 72865-167-60 72865016760 60 TABLET in 1 BOTTLE (72865-167-60) 60 tablet 2021-05-28 0000-00-00 No No Current