Clarithromycin

Product NDC: 57237-045
11-digit product format: 572370045
Labeler code: 57237
Product ID: 57237-045_ce30a7ce-c4f2-41b3-966d-c79fab80f76b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, 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.

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
2026-08-01 22:54:32	2026-06	A065489-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	RS	2012-07-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065489-002	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	RS	2012-07-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A065489-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065489-002	AB	1	`a50c72e98297…`

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
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 ndc (product): 57237-045
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: 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197516	Internal RxNorm lookup
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
0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	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
57237-045-60	Clarithromycin	60 in 1 BOTTLE	TABLET, FILM COATED	60		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-045-60	EA - Each	57237-045	fa053828-7d95-47d2-a240-0bd7f6051b8f	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3
VANILLIN	INACTIVE INGREDIENT	CHI530446X	CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-045	CLARITHROMYCIN TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	17	Current NDC, Legacy NDC, 1 package rows	20240119_0c4db97f-f4c9-4cac-9f12-9db1d967ebeb.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
197516	clarithromycin 250 MG Oral Tablet	PSN	0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	17
197517	clarithromycin 500 MG Oral Tablet	PSN	0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	17
197516	clarithromycin 250 MG Oral Tablet	SCD	0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	17
197517	clarithromycin 500 MG Oral Tablet	SCD	0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	17
197516	clarithromycin 250 MG Oral Tablet	PSN	1920f943-bbf1-cfd9-7475-96a35680a9e0	7
197517	clarithromycin 500 MG Oral Tablet	PSN	1920f943-bbf1-cfd9-7475-96a35680a9e0	7
197516	clarithromycin 250 MG Oral Tablet	SCD	1920f943-bbf1-cfd9-7475-96a35680a9e0	7
197517	clarithromycin 500 MG Oral Tablet	SCD	1920f943-bbf1-cfd9-7475-96a35680a9e0	7
197517	clarithromycin 500 MG Oral Tablet	PSN	b1bdf526-4f16-4130-b614-4cb678f060d7	3
197517	clarithromycin 500 MG Oral Tablet	SCD	b1bdf526-4f16-4130-b614-4cb678f060d7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-045-60	57237004560	60 TABLET, FILM COATED in 1 BOTTLE (57237-045-60)	2012-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarithromycin	AvPAK	2026-02-11	HUMAN PRESCRIPTION DRUG LABEL	7
Clarithromycin	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-01-05	Human Prescription Drug Label	17
Clarithromycin Tablets, USP Rx only	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3