FDA Orange Book
Generic for Cipro
Cipro 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 is ciprofloxacin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 7 of the 8 Cipro products the Orange Book lists.
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Cipro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 250MG/5ML | Marketed (Rx) | AB | 1 | AB |
| for suspension, oral | 500MG/5ML | Marketed (Rx) | AB | 1 | AB |
| injectable, injection | 1200MG/120ML (10MG/ML) | Discontinued | None | 0 | None |
| injectable, injection | 200MG/20ML (10MG/ML) | Discontinued | None | 1 | None |
| injectable, injection | 400MG/40ML (10MG/ML) | Discontinued | None | 1 | None |
| tablet, oral | EQ 250MG BASE | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 500MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | EQ 750MG BASE | Discontinued | None | 8 | AB |
NDA 020780, 019847, 019537, 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 |
|---|---|---|---|---|
| AIPING PHARMACEUTICAL INC | 076593 | AB (A-rated, therapeutically equivalent) | June 9, 2004 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| CARLSBAD TECHNOLOGY INC | 076126 | AB (A-rated, therapeutically equivalent) | June 9, 2004 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| DR REDDYS LABORATORIES LTD | 075593 | AB (A-rated, therapeutically equivalent) | June 9, 2004 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 076089 | AB (A-rated, therapeutically equivalent) | June 9, 2004 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| WATSON LABORATORIES INC | 076794 | AB (A-rated, therapeutically equivalent) | June 9, 2004 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| RISING PHARMA HOLDING INC | 075817 | AB (A-rated, therapeutically equivalent) | June 9, 2004 | EQ 500MG BASE |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 076639 | AB (A-rated, therapeutically equivalent) | September 10, 2004 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| CHARTWELL LIFE MOLECULES LLC | 076896 | AB (A-rated, therapeutically equivalent) | November 4, 2004 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| AUROBINDO PHARMA LTD | 077859 | AB (A-rated, therapeutically equivalent) | April 26, 2007 | EQ 250MG BASE, EQ 500MG BASE, EQ 750MG BASE |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 076717 | None (No TE code listed) | December 22, 2009 | 200MG/20ML (10MG/ML), 400MG/40ML (10MG/ML) |
| CHARTWELL LIFE MOLECULES LLC | 200563 | AB (A-rated, therapeutically equivalent) | March 5, 2014 | 250MG/5ML, 500MG/5ML |
| PHARMOBEDIENT CONSULTING LLC | 208921 | AB (A-rated, therapeutically equivalent) | June 22, 2018 | EQ 250MG BASE, EQ 500MG BASE |
Cipro NDC codes
Questions
Is there a generic for Cipro?
Yes. The generic name for Cipro is ciprofloxacin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 7 of the 8 Cipro products the Orange Book lists.
What is the generic name for Cipro?
The active ingredient in Cipro 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.