FDA Orange Book · active-ingredient family
Cefaclor
Cefaclor: 3 brands, 30 generics; first approved Apr 20, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 30 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
30
Listed patents
0
Presentations
55
Brand (NDA) products
Originator applications
- CECLORRLDLILLYNDA 050521—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CECLORRLDLILLYNDA 050522—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 250MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - LILLYNDA 05067319962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 500MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued —
Generic (ANDA) products (30)
Abbreviated applications
- CEFACLORYUNG SHIN PHARMANDA 06541220124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Rx — EQ 187MG BASE/5ML FOR SUSPENSION ORAL Rx — EQ 250MG BASE/5ML FOR SUSPENSION ORAL Rx — EQ 375MG BASE/5ML FOR SUSPENSION ORAL Rx — - CEFACLORHIKMAANDA 06535020072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CEFACLORYUNG SHIN PHARMANDA 06514620042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Rx — EQ 500MG BASE CAPSULE ORAL Rx — - RANBAXY LABS LTDANDA 06509220034 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 187MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 250MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 375MG BASE TABLET, CHEWABLE ORAL Discontinued — - CEFACLORTEVAANDA 06505820022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE TABLET, EXTENDED RELEASE ORAL Rx — EQ 500MG BASE TABLET, EXTENDED RELEASE ORAL Rx — - CEFACLORWORLD GENANDA 0650572001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - CEFACLORWATSON LABS INCANDA 0642041998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORWATSON LABS INCANDA 0642051998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 187MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORWATSON LABS INCANDA 0642061998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORWATSON LABS INCANDA 0642071998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORRANBAXYANDA 0641661997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORRANBAXYANDA 0641651997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 187MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORRANBAXYANDA 0641641997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORRANBAXYANDA 0641551997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORRANBAXYANDA 06415619972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CEFACLORTEVAANDA 06408119962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CEFACLORTEVAANDA 06414519962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CEFACLORCHARTWELL RXANDA 06414819962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CEFACLORDAVA PHARMS INCANDA 0641141995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORDAVA PHARMS INCANDA 0641151995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 187MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORDAVA PHARMS INCANDA 0641161995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORDAVA PHARMS INCANDA 0641101995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORIVAX SUB TEVA PHARMSANDA 0640871995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORIVAX SUB TEVA PHARMSANDA 0640861995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 187MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORIVAX SUB TEVA PHARMSANDA 0640851995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORIVAX SUB TEVA PHARMSANDA 0640701995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - CEFACLORDAVA PHARMS INCANDA 06410719952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CEFACLORIVAX SUB TEVA PHARMSANDA 06406119952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CEFACLORCEPH INTLANDA 062205—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — EQ 500MG BASE CAPSULE ORAL Discontinued — - CEFACLORFACTA FARMAANDA 062206—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 250MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 187MG BASE/5ML FOR SUSPENSION ORAL Discontinued — EQ 375MG BASE/5ML FOR SUSPENSION 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
38 yr 11 mo ago
Most recent approval
14 yr 9 mo ago
Approvals span 1988–2012 across 33 FDA applications.
Brand (NDA) 39%
Generic (ANDA) 3091%
Cefaclor: 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
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- 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.
