FDA Orange Book
Generic for Cipro XR
Cipro XR 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 Cipro XR is ciprofloxacin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Cipro XR products the Orange Book lists.
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Cipro XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 212.6MG;EQ 287.5MG BASE | Discontinued | None | 0 | None |
| tablet, extended release, oral | 425.2MG;EQ 574.9MG BASE | Discontinued | None | 1 | None |
NDA 021473, held by BAYER HEALTHCARE PHARMACEUTICALS 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 |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 077701 | None (No TE code listed) | March 26, 2007 | 425.2MG;EQ 574.9MG BASE |
Questions
Is there a generic for Cipro XR?
Yes. The generic name for Cipro XR is ciprofloxacin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Cipro XR products the Orange Book lists.
What is the generic name for Cipro XR?
The active ingredient in Cipro XR 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.