clarithromycin

Product NDC: 50090-1410
11-digit product format: 500901410
Labeler code: 50090
Product ID: 50090-1410_b2c904b7-6535-4cd7-b55a-e86772becd42
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clarithromycin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065145
Marketing category: ANDA
Marketing start: 2014-02-27
Marketing end: 0000-00-00
Substance: CLARITHROMYCIN
Active strength: 500 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	50090-1410		D	Discontinued by firm		2026-08-03
excluded package	package	50090-1410	50090-1410-0	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 · 24 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	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	50090-1410		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1410	50090-1410-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A065145-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2004-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065145-001	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	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`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	A065145-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065145-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065145-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065145-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065145-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065145-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065145-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065145-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065145-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065145-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065145-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065145-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065145-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065145-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065145-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065145-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065145-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065145-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065145-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065145-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065145-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065145-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065145-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065145-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065145-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065145-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065145-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065145-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065145-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065145-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065145-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065145-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065145-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065145-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065145-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065145-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065145-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065145-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065145-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065145-001	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
clarithromycin	CLARITHROMYCIN	Actavis Pharma, Inc.	d5be5f12-6392-4d7d-ab23-ebc205ac1a85	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065145 application number: ANDA065145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1410-0	EA - Each	50090-1410	01ce8108-9ccb-43f5-ae78-b0030e6177b3	1	2018-11-06