FDA Orange Book
Generic for Ciloxan
Ciloxan contains ciprofloxacin. 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 Ciloxan is ciprofloxacin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 2 Ciloxan products the Orange Book lists.
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Ciloxan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, ophthalmic | EQ 0.3% BASE | Marketed (Rx) | None | 0 | None |
| solution/drops, ophthalmic | EQ 0.3% BASE | Marketed (Rx) | AT | 5 | AT |
NDA 020369, 019992, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ciprofloxacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RUBICON RESEARCH LTD | 075928 | AT (A-rated, therapeutically equivalent) | June 9, 2004 | EQ 0.3% BASE |
| WATSON LABORATORIES INC | 076673 | AT (A-rated, therapeutically equivalent) | January 21, 2005 | EQ 0.3% BASE |
| RISING PHARMA HOLDINGS INC | 077689 | AT (A-rated, therapeutically equivalent) | December 13, 2006 | EQ 0.3% BASE |
| FDC LTD | 077568 | AT (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 0.3% BASE |
| ALTAIRE PHARMACEUTICALS INC | 204613 | AT (A-rated, therapeutically equivalent) | May 3, 2018 | EQ 0.3% BASE |
Ciloxan NDC codes
Questions
Is there a generic for Ciloxan?
Yes. The generic name for Ciloxan is ciprofloxacin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 1 of the 2 Ciloxan products the Orange Book lists.
What is the generic name for Ciloxan?
The active ingredient in Ciloxan is ciprofloxacin, 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.