FDA Orange Book · active-ingredient family
Clarithromycin
Clarithromycin: 3 brands, 23 generics; first approved Oct 31, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 23 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
23
Listed patents
0
Presentations
43
Brand (NDA) products
Originator applications
- BIAXIN XLRLDABBVIENDA 0507752000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BIAXINRLDABBVIENDA 05069819933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — 187MG/5ML FOR SUSPENSION ORAL Discontinued — - BIAXINRLDABBVIENDA 05066219912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued —
Generic (ANDA) products (23)
Abbreviated applications
- CLARITHROMYCINALEMBICANDA 21045920222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CLARITHROMYCINJUBILANT CADISTAANDA 20671420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CLARITHROMYCINSUNSHINEANDA 2089872018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB - CLARITHROMYCINMPP PHARMAANDA 2032432016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB - CLARITHROMYCINHEC PHARMANDA 20358420152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CLARITHROMYCINLUPINANDA 2025322015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - CLARITHROMYCINNOVITIUM PHARMAANDA 20271020132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CLARITHROMYCINRSAUROBINDOANDA 06548920122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CLARITHROMYCINSANDOZANDA 06528320072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx — 250MG/5ML FOR SUSPENSION ORAL Rx — - CLARITHROMYCINSUN PHARM INDS LTDANDA 06538220072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued — - CLARITHROMYCINCHARTWELLANDA 06538420072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CLARITHROMYCINWOCKHARDTANDA 06526620062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CLARITHROMYCINSANDOZANDA 0651442005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB - CLARITHROMYCINANI PHARMSANDA 0652502005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - CLARITHROMYCINSANDOZANDA 0651362005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - CLARITHROMYCINIVAX SUB TEVA PHARMSANDA 06513720052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CLARITHROMYCINTEVAANDA 06515520052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CLARITHROMYCINRSDR REDDYS LABS SAANDA 0651542005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB - CLARITHROMYCINPHARMOBEDIENTANDA 06519520052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CLARITHROMYCINRANBAXYANDA 0652102005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - CLARITHROMYCINSUN PHARM INDS LTDANDA 06517420042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CLARITHROMYCINACTAVIS LABS FL INCANDA 0651452004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB - CLARITHROMYCINHIKMAANDA 06517820042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
35 yr 4 mo ago
Most recent approval
4 yr 8 mo ago
Approvals span 1991–2022 across 26 FDA applications.
Brand (NDA) 312%
Generic (ANDA) 2388%
Clarithromycin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
