Clarithromycin

Product NDC: 70518-2773
Requested package NDC: 70518-2773-0
11-digit product format: 705182773
Labeler code: 70518
Product ID: 70518-2773_ea39f363-747b-3417-e053-2a95a90ab7d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA065136
Marketing category: ANDA
Marketing start: 2020-06-09
Marketing end: 0000-00-00
Substance: CLARITHROMYCIN
Active strength: 500 mg/1
Pharmacologic classes: Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2773	70518-2773-0	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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
A065136-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL	AB		2005-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065136-001	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	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065136-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2005-08-25	`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	A065136-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065136-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065136-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065136-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065136-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065136-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065136-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065136-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065136-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065136-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065136-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065136-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065136-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065136-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065136-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065136-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065136-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065136-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065136-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065136-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065136-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065136-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065136-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065136-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065136-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065136-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065136-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065136-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065136-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065136-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065136-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065136-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065136-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065136-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065136-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065136-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065136-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065136-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065136-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065136-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2773-0	2022-02-02	C162847	48780-1	d6a99b39-e2ac-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-2773-0	2022-01-28	C162847	48780-1	d6a99b39-e2ac-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	f98aacb4-2f01-3e94-e053-6294a90a9aa0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	0be243c6-de02-45dd-8210-cab1bbc8dfa7	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Coupler LLC	2d6cfd87-9b8c-bba9-e063-6294a90aff5a	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	DirectRx	d22bd12c-737b-4aab-e053-2995a90aff60	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Bryant Ranch Prepack	27e02b77-4332-49e0-8d0c-a072cf5dff92	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	28f60574-4ecd-441c-aebe-5b1d18033ef6	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	adba78c2-9e51-4bed-8c6a-6f977f79c40c	2023-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136
Clarithromycin	CLARITHROMYCIN	Asclemed USA, Inc.	a12e4d38-e0f8-4467-a26c-bb25a342aa92	2020-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065136 application number: ANDA065136

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H1250JIK0A	CLARITHROMYCIN	81103-11-9	CLARITHROMYCIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2773-0	70518277300	30 TABLET in 1 BLISTER PACK (70518-2773-0)	30 tablet	2020-06-09	0000-00-00	No	No	Current