Home NDC 50268-049 Abacavir
Product NDC 50268-049
11-digit product format 502680049
Labeler code 50268
Product ID 50268-049_47e2137a-9afb-1285-e063-6294a90a4979
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA091560
Marketing category ANDA
Marketing start 2020-04-10
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 A091560-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB RS 2013-09-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Abacavir
Listing expiration 2027-12-31 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 50268-049-11 Abacavir 1 in 1 BLISTER PACK TABLET 1 4 50268-049-12 Abacavir 20 in 1 BOX TABLET 20 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-049 ABACAVIR TABLET [AVPAK] 3 Current NDC, Legacy NDC, 2 package rows 20220517_a2f06528-f3c5-2466-e053-2995a90ae18a.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 · 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 ndc (product): 50268-049 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
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 50268-049-11 50268004911 1 in 1 BLISTER PACK Historical 50268-049-12 50268004912 20 BLISTER PACK in 1 BOX (50268-049-12) / 1 TABLET in 1 BLISTER PACK (50268-049-11) 20 blister pack 2020-04-10 0000-00-00 No No Current