Abacavir

Product NDC: 70518-1274
11-digit product format: 705181274
Labeler code: 70518
Product ID: 70518-1274_f05a16e4-0e69-224c-e053-2a95a90a90e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Abacavir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078119
Marketing category: ANDA
Marketing start: 2018-06-21
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-1274		D	Discontinued by firm		2026-08-03
excluded package	package	70518-1274	70518-1274-0	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70518-1274		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1274	70518-1274-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	70518-1274		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1274	70518-1274-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078119-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078119-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078119-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078119-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078119-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078119-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078119-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078119-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078119-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078119-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078119-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078119-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078119-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078119-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078119-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078119-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078119-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078119-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078119-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078119-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078119-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078119-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078119-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078119-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078119-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078119-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078119-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078119-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078119-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078119-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078119-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078119-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078119-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078119-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078119-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078119-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078119-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078119-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078119-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078119-001	AB	1	`cb3db0bc1861…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abacavir	ABACAVIR	Cipla USA Inc.	0d791375-e311-41f9-87b8-940657e6318c	2020-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078119 application number: ANDA078119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-1274-0	EA - Each	70518-1274	bf682013-e0e5-4940-aece-99402262675a	1	2023-01-09

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J220T4J9Q2	ABACAVIR SULFATE	188062-50-2	ABACAVIR SULFATE
WR2TIP26VS	ABACAVIR	136470-78-5	Abacavir

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1274-0	70518127400	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1274-0)	2018-06-21	0000-00-00	No	No	Current