FDA Orange Book

Generic for Ceclor

Ceclor contains cefaclor. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Ceclor is cefaclor. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

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Ceclor products in the Orange Book

Ceclor products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 250MG BASEDiscontinuedNone1None
capsule, oralEQ 500MG BASEDiscontinuedNone1None
for suspension, oralEQ 125MG BASE/5MLDiscontinuedNone1None
for suspension, oralEQ 250MG BASE/5MLDiscontinuedNone1None

NDA 050521, 050522, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic cefaclor

Approved generic versions of Ceclor
CompanyANDATE codeApprovedStrengths
YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD065146None (No TE code listed)January 22, 2004EQ 250MG BASE, EQ 500MG BASE
YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD065412None (No TE code listed)February 17, 2012EQ 125MG BASE/5ML, EQ 250MG BASE/5ML

Questions

Is there a generic for Ceclor?

Yes. The generic name for Ceclor is cefaclor. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

What is the generic name for Ceclor?

The active ingredient in Ceclor is cefaclor, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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