Clarithromycin

Product NDC: 50090-5282
11-digit product format: 500905282
Labeler code: 50090
Product ID: 50090-5282_81455578-b702-45f6-b99c-22968f4a4f38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065136
Marketing category: ANDA
Marketing start: 2005-08-25
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clarithromycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLARITHROMYCIN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H1250JIK0A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197517	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
adba78c2-9e51-4bed-8c6a-6f977f79c40c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2	Product name	7	20221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5282-0	2023-02-07	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
50090-5282-1	2023-02-07	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
50090-5282-2	2023-02-07	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
50090-5282-0	2023-01-30	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
50090-5282-1	2023-01-30	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
50090-5282-2	2023-01-30	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-5282-0	Clarithromycin	20 in 1 BOTTLE	TABLET	20	8
50090-5282-1	Clarithromycin	30 in 1 BOTTLE	TABLET	30	8
50090-5282-2	Clarithromycin	14 in 1 BOTTLE	TABLET	14	8
50090-5282-3	Clarithromycin	28 in 1 BOTTLE	TABLET	28	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5282-0	EA - Each	50090-5282	d297645d-017e-436f-a3a3-88c344893e51	1	2023-07-06
50090-5282-1	EA - Each	50090-5282	1a4e27d1-1fad-4aca-b89a-945a2d48c1e8	1	2023-07-06
50090-5282-2	EA - Each	50090-5282	f14c2e97-527b-43cf-90d9-f4e8bd9697f6	1	2023-07-06
50090-5282-3	EA - Each	50090-5282	a45b1d26-24ab-49b6-8109-887532e5ca4e	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5282	CLARITHROMYCIN TABLET [A-S MEDICATION SOLUTIONS]	8	Current NDC, Legacy NDC, 4 package rows	20231215_adba78c2-9e51-4bed-8c6a-6f977f79c40c.zip

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 ndc (product): 50090-5282
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197517	clarithromycin 500 MG Oral Tablet	PSN	adba78c2-9e51-4bed-8c6a-6f977f79c40c	8
197517	clarithromycin 500 MG Oral Tablet	SCD	adba78c2-9e51-4bed-8c6a-6f977f79c40c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5282-0	50090528200	20 TABLET in 1 BOTTLE (50090-5282-0)	20 tablet	2020-10-22	0000-00-00	No	No	Current
50090-5282-1	50090528201	30 TABLET in 1 BOTTLE (50090-5282-1)	30 tablet	2020-10-22	0000-00-00	No	No	Current
50090-5282-2	50090528202	14 TABLET in 1 BOTTLE (50090-5282-2)	14 tablet	2020-10-22	0000-00-00	No	No	Current
50090-5282-3	50090528203	28 TABLET in 1 BOTTLE (50090-5282-3)	28 tablet	2023-12-11		No	No	Current