Application 065178

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARITHROMYCIN	CLARITHROMYCIN	TABLET;ORAL	500MG	No	No
002	CLARITHROMYCIN	CLARITHROMYCIN	TABLET;ORAL	250MG	No	No

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
A065178-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL			2004-05-25
A065178-002	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL			2004-05-25

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2004-05-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2004-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065178-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065178-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A065178-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065178-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065178-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065178-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065178-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065178-002	AB	1	`ea99ee380514…`

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 3 · 42 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	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	REMEDYREPACK INC.	9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Sportpharm LLC	de33ba3a-9df1-4076-8d5f-b603d2698096	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Solaris Pharma Corporation	4d42821d-ce7a-7d64-e063-6294a90a0875	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	88c7ded8-333c-408d-b693-a72881710f59	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Preferred Pharmaceuticals Inc.	81c0c69e-b1ae-42f3-9e85-09b8daa75d8d	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Major Pharmaceuticals	d0a66646-6774-4fc6-9b26-a98c3a5df274	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	American Health Packaging	59ebe6cb-c830-45c7-8242-52f9f42a90a0	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Solaris Pharma Corporation	4d4303f8-88dd-8b88-e063-6394a90ab48f	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	American Health Packaging	fa69ea92-0b41-43fb-918f-ed80e0dedf04	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	fad1e5a3-59f9-4868-9937-d3b061ab8f00	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	AvPAK	1920f943-bbf1-cfd9-7475-96a35680a9e0	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	471f638a-9dd1-09d3-e063-6294a90a2d4f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Northwind Health Company, LLC	f98aacb4-2f01-3e94-e053-6294a90a9aa0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
CLARITHROMYCIN	CLARITHROMYCIN	Chartwell RX, LLC	dea5bd78-7f93-4bc4-a2e4-1b021f5fe098	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: CLARITHROMYCIN generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	9eb306e0-ccfb-418c-82ca-204f20a788f7	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	1d328f5d-73c1-4df7-a3df-71d0e0221181	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	1cb8a78a-0f07-49e8-a23e-a77628006209	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	0be243c6-de02-45dd-8210-cab1bbc8dfa7	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Direct_Rx	3ba1da51-ba5b-323f-e063-6294a90a0333	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0036	Clarithromycin	clarithromycin	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0037	Clarithromycin	clarithromycin	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0037	Clarithromycin	clarithromycin	West-Ward Pharmaceuticals Corp.	ANDA	Current
10544-952	Clarithromycin	clarithromycin	Blenheim Pharmacal, Inc.	ANDA	Current
63629-2887	Clarithromycin	clarithromycin	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23737	ORIG	2006-03-03