Clarithromycin

Product NDC: 49999-904
11-digit product format: 499990904
Labeler code: 49999
Product ID: 49999-904_69bb95fd-e7cb-4458-9307-efceaacdbe9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA065136
Marketing category: ANDA
Marketing start: 2010-11-15
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: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49999-904		D	Discontinued by firm	2026-08-03
excluded package	package	49999-904	49999-904-14	D	Discontinued by firm	2026-08-03
excluded package	package	49999-904	49999-904-20	D	Discontinued by firm	2026-08-03
excluded package	package	49999-904	49999-904-30	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 · 48 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	49999-904-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49999-904-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49999-904-20	`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	49999-904-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49999-904-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49999-904-20	`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	49999-904-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49999-904-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49999-904-20	`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	49999-904-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49999-904-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49999-904-20	`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	49999-904-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49999-904-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49999-904-20	`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	49999-904-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49999-904-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49999-904-20	`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	49999-904-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49999-904-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49999-904-20	`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	49999-904-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49999-904-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49999-904-20	`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	49999-904-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49999-904-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49999-904-20	`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	49999-904-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49999-904-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49999-904-20	`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	49999-904-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49999-904-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49999-904-20	`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	49999-904-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49999-904-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49999-904-20	`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
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-904-14	EA - Each	49999-904	03ec753e-83c6-43f5-a17f-2604658448fe	1	2012-07-24
49999-904-20	EA - Each	49999-904	11516884-f3dd-4356-931d-8d90c2d12963	1	2012-07-24
49999-904-30	EA - Each	49999-904	be4c389a-3f1c-4bad-812e-a4b9e4517d1b	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3350

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	Marketing start	Marketing end	Sample	Exclude flag	Status
49999-904-14	49999090414	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-904-14)	2010-11-15	0000-00-00	No	No	Current
49999-904-20	49999090420	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-904-20)	2010-11-15	0000-00-00	No	No	Current
49999-904-30	49999090430	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-904-30)	2010-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarithroymycin 500mg	Lake Erie Medical DBA Quality Care Products LLC	2020-05-19	HUMAN PRESCRIPTION DRUG LABEL	3352