Clarithromycin

Product NDC: 43063-823
11-digit product format: 430630823
Labeler code: 43063
Product ID: 43063-823_3ba20925-0d1d-3712-e063-6394a90aa41b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
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: 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 · 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…`

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
ba216276-b0bd-420a-9e0d-090bdfcc2460	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
43063-823-20	Clarithromycin	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20		27
43063-823-28	Clarithromycin	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-823-20	EA - Each	43063-823	6deb23ed-9495-4a53-a7a4-9d13ca018f25	1	2018-02-20
43063-823-28	EA - Each	43063-823	98f74e60-abaa-4871-b8e3-534f1d63ec8b	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-823	CLARITHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	26	Current NDC, Legacy NDC, 2 package rows	20240703_ba216276-b0bd-420a-9e0d-090bdfcc2460.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 · 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 ndc (product): 43063-823
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

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	ba216276-b0bd-420a-9e0d-090bdfcc2460	27
197517	clarithromycin 500 MG Oral Tablet	SCD	ba216276-b0bd-420a-9e0d-090bdfcc2460	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-823-20	43063082320	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20)	2018-01-08	0000-00-00	No	No	Current
43063-823-28	43063082328	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-28)	2018-02-22	0000-00-00	No	No	Current