clarithromycin

Product NDC: 0591-2805
11-digit product format: 005912805
Labeler code: 0591
Product ID: 0591-2805_d97b84fc-7e0b-4f73-804d-522c2448b058
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clarithromycin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA065145
Marketing category: ANDA
Marketing start: 2014-02-27
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
A065145-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2004-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065145-001	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	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065145-001	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-06-24	`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	A065145-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065145-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065145-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065145-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065145-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065145-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065145-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065145-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065145-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065145-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065145-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065145-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065145-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065145-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065145-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065145-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065145-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065145-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065145-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065145-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065145-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065145-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065145-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065145-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065145-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065145-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065145-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065145-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065145-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065145-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065145-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065145-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065145-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065145-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065145-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065145-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065145-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065145-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065145-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065145-001	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
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
d5be5f12-6392-4d7d-ab23-ebc205ac1a85	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
0591-2805-60	clarithromycin	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60		37

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	27
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2805	CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	37	Current NDC, Legacy NDC, 1 package rows	20250411_d5be5f12-6392-4d7d-ab23-ebc205ac1a85.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clarithromycin	CLARITHROMYCIN	Actavis Pharma, Inc.	d5be5f12-6392-4d7d-ab23-ebc205ac1a85	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065145 application number: ANDA065145 ndc (product): 0591-2805

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	d5be5f12-6392-4d7d-ab23-ebc205ac1a85	37
359385	24 HR clarithromycin 500 MG Extended Release Oral Tablet	SCD	d5be5f12-6392-4d7d-ab23-ebc205ac1a85	37
359385	clarithromycin 500 MG 24 HR Extended Release Oral Tablet	SY	d5be5f12-6392-4d7d-ab23-ebc205ac1a85	37
359385	clarithromycin 500 MG 24HR Extended Release Oral Tablet	PSN	4e79245f-ecfd-04c4-e054-00144ff88e88	3
359385	24 HR clarithromycin 500 MG Extended Release Oral Tablet	SCD	4e79245f-ecfd-04c4-e054-00144ff88e88	3
359385	clarithromycin 500 MG 24 HR Extended Release Oral Tablet	SY	4e79245f-ecfd-04c4-e054-00144ff88e88	3
359385	clarithromycin 500 MG 24HR Extended Release Oral Tablet	PSN	2b5aef5f-d96e-55e0-e054-00144ff8d46c	1
359385	24 HR clarithromycin 500 MG Extended Release Oral Tablet	SCD	2b5aef5f-d96e-55e0-e054-00144ff8d46c	1
359385	clarithromycin 500 MG 24 HR Extended Release Oral Tablet	SY	2b5aef5f-d96e-55e0-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2805-60	00591280560	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2805-60)	2014-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
clarithromycin	Actavis Pharma, Inc.	2025-04-10	HUMAN PRESCRIPTION DRUG LABEL	37
clarithromycin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
clarithromycin	PD-Rx Pharmaceuticals, Inc.	2021-09-02	HUMAN PRESCRIPTION DRUG LABEL	37
clarithromycin	PD-Rx Pharmaceuticals, Inc.	2021-09-02	HUMAN PRESCRIPTION DRUG LABEL	36
clarithromycin	Preferred Pharmaceuticals Inc.	2019-07-31	HUMAN PRESCRIPTION DRUG LABEL	3
clarithromycin	A-S Medication Solutions	2019-04-11	HUMAN PRESCRIPTION DRUG LABEL	12
Clarithromycin Extended-Release Tablets, USP	AvKARE, Inc.	2018-01-19	HUMAN PRESCRIPTION DRUG LABEL	3
CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USP	Department of State Health Services, Pharmacy Branch	2016-02-09	HUMAN PRESCRIPTION DRUG LABEL	1