Home NDC 69097-514 Abacavir
Product NDC 69097-514
11-digit product format 690970514
Labeler code 69097
Product ID 69097-514_cf84089d-b713-40b8-a815-b66f4119982e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cipla USA Inc.
Application ANDA078119
Marketing category ANDA
Marketing start 2017-11-21
Substance ABACAVIR SULFATE
Active strength 300 mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], 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 A078119-001 ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078119-001 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 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078119-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2017-11-21 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 69097-514-03 Abacavir 60 in 1 BOTTLE TABLET, FILM COATED 60 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-514 ABACAVIR TABLET, FILM COATED [CIPLA USA INC.] 9 Current NDC, Legacy NDC, 1 package rows 20201231_0d791375-e311-41f9-87b8-940657e6318c.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 · 1 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 69097-514-03 69097051403 60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03) 2017-11-21 0000-00-00 No No Current