Clarithromycin

Product NDC: 68071-1899
11-digit product format: 680711899
Labeler code: 68071
Product ID: 68071-1899_4b7dbff8-c9af-1d20-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA065489
Marketing category: ANDA
Marketing start: 2012-07-25
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: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-1899		D	Discontinued by firm	2026-08-03
excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	2026-08-03
excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	2026-08-03
excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	2026-08-03
excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 2 · 65 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

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	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-1899	68071-1899-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	68071-1899		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1899	68071-1899-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1899	68071-1899-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1899	68071-1899-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1899	68071-1899-4	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065489-001	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25
A065489-002	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065489-001	AB
A065489-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A065489-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065489-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065489-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065489-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065489-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065489-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065489-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065489-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065489-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065489-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065489-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065489-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065489-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065489-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065489-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065489-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065489-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065489-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065489-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065489-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065489-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065489-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065489-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065489-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065489-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065489-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065489-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065489-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065489-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065489-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065489-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065489-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065489-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065489-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065489-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065489-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065489-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065489-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065489-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065489-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Sportpharm LLC	d836ae7e-fdbf-4dcb-a90d-ede1dcbc3e67	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	REMEDYREPACK INC.	9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	88c7ded8-333c-408d-b693-a72881710f59	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Preferred Pharmaceuticals Inc.	81c0c69e-b1ae-42f3-9e85-09b8daa75d8d	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Major Pharmaceuticals	d0a66646-6774-4fc6-9b26-a98c3a5df274	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	American Health Packaging	fa69ea92-0b41-43fb-918f-ed80e0dedf04	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	AvPAK	1920f943-bbf1-cfd9-7475-96a35680a9e0	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	471f638a-9dd1-09d3-e063-6294a90a2d4f	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Direct_Rx	3ba1da51-ba5b-323f-e063-6294a90a0333	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	ba216276-b0bd-420a-9e0d-090bdfcc2460	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	25debd85-0840-4f8d-9898-027772061dd2	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	NuCare Pharmaceuticals,Inc.	9143b79c-4c79-43ac-e053-2995a90ad708	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Bryant Ranch Prepack	0c7d8391-50ef-4827-abe6-e0fc0c2f1636	2024-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Rising Pharma Holdings, Inc.	0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Aurobindo Pharma Limited	9aaffb41-408c-4372-8fd5-1d649450c0e9	2023-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23	2023-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	b1bdf526-4f16-4130-b614-4cb678f060d7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065489 application number: ANDA065489

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1899-2	2020-08-05	C162847	48780-1	9d75b9cf-fd2e-f424-e053-dadaa90a57ce	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
68071-1899-3	2020-08-05	C162847	48780-1	9d75b9cf-fd2e-f424-e053-dadaa90a57ce	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
68071-1899-4	2020-08-05	C162847	48780-1	9d75b9cf-fd2e-f424-e053-dadaa90a57ce	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
68071-1899-8	2020-08-05	C162847	48780-1	9d75b9cf-fd2e-f424-e053-dadaa90a57ce	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
68071-1899-2	2020-01-31	C162847	48780-1	9d75b9cf-fd2e-f424-e053-dadaa90a57ce	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
68071-1899-3	2020-01-31	C162847	48780-1	9d75b9cf-fd2e-f424-e053-dadaa90a57ce	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
68071-1899-4	2020-01-31	C162847	48780-1	9d75b9cf-fd2e-f424-e053-dadaa90a57ce	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
68071-1899-8	2020-01-31	C162847	48780-1	9d75b9cf-fd2e-f424-e053-dadaa90a57ce	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