Clarithromycin

Product NDC: 0904-6872
11-digit product format: 009046872
Labeler code: 0904
Product ID: 0904-6872_d4f040b6-4684-4131-931e-8d8272fadaee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA065489
Marketing category: ANDA
Marketing start: 2012-07-25
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: 2027-12-31
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 · 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 ndc (product): 0904-6872
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

Additional Listing Data#

Finished product: Yes
Brand name base: Clarithromycin
Listing expiration: 2027-12-31

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
d0a66646-6774-4fc6-9b26-a98c3a5df274	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6872-04	Clarithromycin	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		5
0904-6872-04	Clarithromycin	30 in 1 CARTON	TABLET, FILM COATED	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6872-04	EA - Each	0904-6872	c0e761d3-f139-475f-b359-029b6f71531a	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6872	CLARITHROMYCIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	4	Current NDC, Legacy NDC, 2 package rows	20250313_d0a66646-6774-4fc6-9b26-a98c3a5df274.zip

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	d0a66646-6774-4fc6-9b26-a98c3a5df274	5
197517	clarithromycin 500 MG Oral Tablet	SCD	d0a66646-6774-4fc6-9b26-a98c3a5df274	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6872-04	00904687204	30 BLISTER PACK in 1 CARTON (0904-6872-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK	30 blister pack	2012-07-25	0000-00-00	No	No	Current