Abacavir and Lamivudine

Product NDC: 65862-335
11-digit product format: 658620335
Labeler code: 65862
Product ID: 65862-335_7fbb109d-29d0-4439-b4ef-00c587cc6099
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Abacavir and Lamivudine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090159
Marketing category: ANDA
Marketing start: 2018-11-15
Substance: ABACAVIR SULFATE; LAMIVUDINE
Active strength: 600; 300 mg/1; mg/1
Pharmacologic classes: Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], 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	65862-335		UNFINISHED	Active or certified unfinished drug listing		2026-10-05
unfinished package	package	65862-335	65862-335-99	UNFINISHED	Active or certified unfinished drug listing		2026-10-05

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-335-99	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-335-99	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-335-99	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-335-99	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-335-99	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-335-99	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-335-99	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-335-99	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-335-99	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-335-99	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-335-99	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-335-99	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-335-99	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-335-99	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-335-99	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-335-99	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-335-99	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-335-99	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-335-99	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-335-99	`263afe128892…`	`91768de4ddbe…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB		2018-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090159-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090159-001	ABACAVIR SULFATE AND LAMIVUDINE	EQ 600MG BASE;300MG	TABLET / ORAL	AB	2018-11-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090159-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090159-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090159-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090159-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090159-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090159-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090159-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090159-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090159-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090159-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090159-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090159-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090159-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090159-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090159-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090159-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090159-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090159-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090159-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090159-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090159-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090159-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090159-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090159-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090159-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090159-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090159-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090159-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090159-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090159-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090159-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090159-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090159-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090159-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090159-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090159-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090159-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090159-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090159-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090159-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Abacavir and Lamivudine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ABACAVIR SULFATE	600 mg/1
LAMIVUDINE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J220T4J9Q2	Internal UNII lookup
2T8Q726O95	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
602393	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
deda1a24-2f51-4601-9881-347f47270940	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
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8e	Product name	8	20250626
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
3832141c-c294-474a-9473-1052c891450e	Product name	2	20230105
320f244d-8b4e-4893-9f14-104b2a8e0aaf	Product name	2	20201007
7ff71f22-5b66-4a3d-bf64-671893a6409d	Product name	2	20201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47e	Product name	1	20190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68	Product name	3	20190627
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1	Product name	7	20181210
d07e0b9e-e041-41dc-942a-a2a6601dc221	Product name	1	20181029
e1e3cf65-28b8-ebf3-c11f-d11a82e0862a	Product name	4	20180604
af19b329-4f44-cd81-491a-fbb7fe7a079f	Product name	2	20151013
c873f14e-2add-4d53-b9b3-bf775efd3702	Product name	1	20150325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-335-10	Abacavir and Lamivudine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	7
65862-335-10	Abacavir and Lamivudine	10 in 1 CARTON	TABLET, FILM COATED	10	7
65862-335-30	Abacavir and Lamivudine	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
65862-335-30	Abacavir and Lamivudine	1 in 1 CARTON	TABLET, FILM COATED	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-335-30	EA - Each	65862-335	397b7e6c-8943-4a92-8aff-4224b4de1c8f	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-335	ABACAVIR AND LAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7	Current NDC, Legacy NDC, 4 package rows	20240521_deda1a24-2f51-4601-9881-347f47270940.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abacavir and Lamivudine	ABACAVIR AND LAMIVUDINE	Aurobindo Pharma Limited	deda1a24-2f51-4601-9881-347f47270940	2024-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090159 application number: ANDA090159 ndc (product): 65862-335

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J220T4J9Q2	ABACAVIR SULFATE	188062-50-2	ABACAVIR SULFATE
2T8Q726O95	LAMIVUDINE	134678-17-4	LAMIVUDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
602393	abacavir sulfate 600 MG / lamiVUDine 300 MG Oral Tablet	PSN	deda1a24-2f51-4601-9881-347f47270940	7
602393	abacavir 600 MG / lamivudine 300 MG Oral Tablet	SCD	deda1a24-2f51-4601-9881-347f47270940	7
602393	abacavir (as abacavir sulfate) 600 MG / lamivudine 300 MG Oral Tablet	SY	deda1a24-2f51-4601-9881-347f47270940	7
602393	abacavir 600 MG / 3TC 300 MG Oral Tablet	SY	deda1a24-2f51-4601-9881-347f47270940	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-335-10	65862033510	10 BLISTER PACK in 1 CARTON (65862-335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2018-11-15	0000-00-00	No	No	Current
65862-335-30	65862033530	1 BOTTLE in 1 CARTON (65862-335-30) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2018-11-15	0000-00-00	No	No	Current
65862-335-99	65862033599	1000 TABLET, FILM COATED in 1 BAG (65862-335-99)		15-NOV-18				Current