Home NDC 48433-001 Abacavir Sulfate
Product NDC 48433-001
11-digit product format 484330001
Labeler code 48433
Product ID 48433-001_4c48242c-1749-1a49-e063-6294a90ac81d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Safecor Health, LLC
Application ANDA091294
Marketing category ANDA
Marketing start 2026-02-23
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 A091294-001 ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091294-001 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 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 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 Sulfate
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 48433-001-01 Abacavir Sulfate 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 48433-001-06 Abacavir Sulfate 50 in 1 CARTON TABLET, FILM COATED 50 2
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 Sample Exclude flag Status 48433-001-01 48433000101 1 in 1 BLISTER PACK Historical 48433-001-06 48433000106 50 BLISTER PACK in 1 CARTON (48433-001-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-001-01) 50 blister pack 2026-02-23 No No Current