Lansoprazole, Amoxicillin and Clarithromycin

Product NDC: 0781-4054
11-digit product format: 007814054
Labeler code: 0781
Product ID: 0781-4054_f47e9091-ddb1-48d3-95f9-92d0c6e0327a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lansoprazole, Amoxicillin and Clarithromycin
Dosage form: KIT
Labeler: Sandoz Inc
Application: ANDA202588
Marketing category: ANDA
Marketing start: 2014-03-04
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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	0781-4054		D	Discontinued by firm		2026-10-15
excluded package	package	0781-4054	0781-4054-42	D	Discontinued by firm		2026-10-15

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 · 24 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 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-4054-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-4054-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-4054-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-4054-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-4054-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-4054-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-4054-42	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-4054-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-4054-42	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-4054-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-4054-42	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-4054-42	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202588-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	AB	2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	AB	2014-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	AB	2014-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	AB	2014-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	AB	2014-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	AB	2014-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	AB	2014-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	AB	2014-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202588-001	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-03-04	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A202588-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202588-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202588-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202588-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202588-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202588-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202588-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202588-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202588-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202588-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202588-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202588-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202588-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202588-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202588-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202588-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202588-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202588-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202588-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202588-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202588-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202588-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202588-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202588-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202588-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202588-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202588-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202588-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202588-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202588-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202588-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202588-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202588-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202588-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202588-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202588-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202588-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202588-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202588-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202588-001	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-4054-42	2020-08-27	C162847	48780-1	ab0e2407-32aa-f274-e053-dbdaa90a6471	triple therapy Lansoprazole Delayed-Release Capsules USP, 30 mg Amoxicillin Capsules USP, 500 mg Clarithromycin Tablets USP, 500 mg
0781-4054-42	2020-07-22	C162847	48780-1	ab0e2407-32aa-f274-e053-dbdaa90a6471	triple therapy Lansoprazole Delayed-Release Capsules USP, 30 mg Amoxicillin Capsules USP, 500 mg Clarithromycin Tablets USP, 500 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-4054-32	EA - Each	0781-4054	5d2392bd-ac55-4d8e-bb0d-a430a6763b08	1	2014-05-02
0781-4054-42	EA - Each	0781-4054	2b18d3de-c901-4e11-a5f0-9d5f49327d25	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
GLYCERYL 1-OLEATE	INACTIVE INGREDIENT	D3AEF6S35P	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN KIT [SANDOZ INC]	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-4054-42	00781405442	14 BLISTER PACK in 1 CARTON (0781-4054-42) > 1 KIT in 1 BLISTER PACK (0781-4054-32)	14 blister pack	2014-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole, Amoxicillin and Clarithromycin	Sandoz Inc	2021-07-15	HUMAN PRESCRIPTION DRUG LABEL	19