Clarithromycin

Product NDC: 43063-942
11-digit product format: 430630942
Labeler code: 43063
Product ID: 43063-942_415eafd4-5d9c-7a6d-e063-6294a90a0f28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA208987
Marketing category: ANDA
Marketing start: 2019-09-10
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 42.

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
A208987-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208987-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208987-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208987-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208987-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208987-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208987-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208987-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208987-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208987-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208987-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208987-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208987-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208987-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208987-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208987-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208987-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208987-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208987-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208987-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208987-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208987-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208987-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208987-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208987-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208987-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208987-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208987-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208987-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208987-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208987-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208987-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208987-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208987-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208987-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208987-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208987-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208987-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208987-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208987-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208987-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208987-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208987-001	AB	1	`e64feba35796…`

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
359385	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
1d328f5d-73c1-4df7-a3df-71d0e0221181	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
43063-942-14	Clarithromycin	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	14		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-942-14	EA - Each	43063-942	90451105-9196-42cd-a027-a162ecfca428	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-942	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20240704_1d328f5d-73c1-4df7-a3df-71d0e0221181.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Solaris Pharma Corporation	4d4303f8-88dd-8b88-e063-6394a90ab48f	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208987 application number: ANDA208987
CLARITHROMYCIN	CLARITHROMYCIN	Chartwell RX, LLC	dea5bd78-7f93-4bc4-a2e4-1b021f5fe098	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208987 application number: ANDA208987
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	1d328f5d-73c1-4df7-a3df-71d0e0221181	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208987 application number: ANDA208987 ndc (product): 43063-942
Clarithromycin	CLARITHROMYCIN	Lannett Company, Inc.	71a836d0-d60f-6418-e053-2a95a90aa6ef	2023-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208987 application number: ANDA208987

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
359385	clarithromycin 500 MG 24HR Extended Release Oral Tablet	PSN	1d328f5d-73c1-4df7-a3df-71d0e0221181	12
359385	24 HR clarithromycin 500 MG Extended Release Oral Tablet	SCD	1d328f5d-73c1-4df7-a3df-71d0e0221181	12
359385	clarithromycin 500 MG 24 HR Extended Release Oral Tablet	SY	1d328f5d-73c1-4df7-a3df-71d0e0221181	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-942-14	43063094214	14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-942-14)	2019-09-10	0000-00-00	No	No	Current