Abacavir

Product NDC: 65862-073
11-digit product format: 658620073
Labeler code: 65862
Product ID: 65862-073_6aae2ecb-8c31-48c8-9e6d-6b41c5ab4da4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Abacavir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA077844
Marketing category: ANDA
Marketing start: 2012-12-17
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

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
unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing		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 · 42 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 21:27 UTC · source 2025-12-05	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product	65862-073		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-073	65862-073-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A077844-001	ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2012-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077844-001	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	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077844-001	ABACAVIR SULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-12-17	`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	A077844-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077844-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077844-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077844-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077844-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077844-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077844-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077844-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077844-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077844-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077844-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077844-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077844-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077844-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077844-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077844-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077844-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077844-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077844-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077844-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077844-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077844-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077844-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077844-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077844-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077844-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077844-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077844-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077844-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077844-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077844-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077844-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077844-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077844-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077844-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077844-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077844-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077844-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077844-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077844-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abacavir	ABACAVIR	Major Pharmaceuticals	4b286ec6-68a7-4ec0-af07-5a27ec9cb35d	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077844 application number: ANDA077844
Abacavir	ABACAVIR	American Health Packaging	01e46f58-8bda-4ff3-ab21-57d5b540d440	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077844 application number: ANDA077844
Abacavir	ABACAVIR	Aurobindo Pharma Limited	5409c8ed-17c3-454f-bb88-d597ba8f84ec	2024-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077844 application number: ANDA077844 ndc (product): 65862-073

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5409c8ed-17c3-454f-bb88-d597ba8f84ec	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
aaa99659-c62c-7281-d402-9590409850c2	Product name	6	20260128
3832141c-c294-474a-9473-1052c891450e	Product name	2	20230105
e1e3cf65-28b8-ebf3-c11f-d11a82e0862a	Product name	4	20180604
af19b329-4f44-cd81-491a-fbb7fe7a079f	Product name	2	20151013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65862-073-60	Abacavir	60 in 1 BOTTLE	TABLET, FILM COATED	60		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-073-60	EA - Each	65862-073	0230c533-6540-4dc1-9101-f6fe540d57bc	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ABACAVIR SULFATE	ACTIVE INGREDIENT	J220T4J9Q2	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
ABACAVIR	ACTIVE MOIETY	WR2TIP26VS	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
ABACAVIR SULFATE	ACTIVE INGREDIENT	J220T4J9Q2	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
ABACAVIR	ACTIVE MOIETY	WR2TIP26VS	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-073	ABACAVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	16	Current NDC, Legacy NDC, 1 package rows	20240507_5409c8ed-17c3-454f-bb88-d597ba8f84ec.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
242679	abacavir 300 MG Oral Tablet	PSN	5409c8ed-17c3-454f-bb88-d597ba8f84ec	16
242679	abacavir 300 MG Oral Tablet	SCD	5409c8ed-17c3-454f-bb88-d597ba8f84ec	16
242679	abacavir (as abacavir sulfate) 300 MG Oral Tablet	SY	5409c8ed-17c3-454f-bb88-d597ba8f84ec	16
242679	abacavir 300 MG Oral Tablet	PSN	01e46f58-8bda-4ff3-ab21-57d5b540d440	7
242679	abacavir 300 MG Oral Tablet	SCD	01e46f58-8bda-4ff3-ab21-57d5b540d440	7
242679	abacavir (as abacavir sulfate) 300 MG Oral Tablet	SY	01e46f58-8bda-4ff3-ab21-57d5b540d440	7
242679	abacavir 300 MG Oral Tablet	PSN	4b286ec6-68a7-4ec0-af07-5a27ec9cb35d	6
242679	abacavir 300 MG Oral Tablet	SCD	4b286ec6-68a7-4ec0-af07-5a27ec9cb35d	6
242679	abacavir (as abacavir sulfate) 300 MG Oral Tablet	SY	4b286ec6-68a7-4ec0-af07-5a27ec9cb35d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-073-18	65862007318	1800 TABLET, FILM COATED in 1 BAG (65862-073-18)	17-DEC-12				Current
65862-073-60	65862007360	60 TABLET, FILM COATED in 1 BOTTLE (65862-073-60)	2012-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Abacavir	Major Pharmaceuticals	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	6
Abacavir	American Health Packaging	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	7
Abacavir	Aurobindo Pharma Limited	2024-05-05	Human Prescription Drug Label	16
Abacavir	REMEDYREPACK INC.	2020-04-07	HUMAN PRESCRIPTION DRUG LABEL	4