FDA Orange Book
Generic for Rocephin
Rocephin contains ceftriaxone. 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 Rocephin is ceftriaxone. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Rocephin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 10GM BASE/VIAL | Discontinued | None | 5 | AP |
| injectable, intramuscular, intravenous | EQ 1GM BASE/VIAL | Discontinued | None | 4 | AP |
| injectable, intramuscular, intravenous | EQ 250MG BASE/VIAL | Discontinued | None | 5 | AP |
| injectable, intramuscular, intravenous | EQ 2GM BASE/VIAL | Discontinued | None | 5 | AP |
| injectable, intramuscular, intravenous | EQ 500MG BASE/VIAL | Discontinued | None | 5 | AP |
NDA 050585, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ceftriaxone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 065169 | AP (A-rated, therapeutically equivalent) | May 9, 2005 | EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| SANDOZ INC | 065168 | AP (A-rated, therapeutically equivalent) | May 17, 2005 | EQ 10GM BASE/VIAL |
| WOCKHARDT BIO AG | 065391 | AP (A-rated, therapeutically equivalent) | April 12, 2007 | EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 065342 | AP (A-rated, therapeutically equivalent) | January 10, 2008 | EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| EPIC PHARMA LLC | 065305 | AP (A-rated, therapeutically equivalent) | January 11, 2008 | EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| ACS DOBFAR SPA | 065328 | AP (A-rated, therapeutically equivalent) | July 24, 2008 | EQ 10GM BASE/VIAL |
| QILU ANTIBIOTICS PHARMACEUTICAL CO LTD | 203702 | AP (A-rated, therapeutically equivalent) | June 29, 2016 | EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| ANDA REPOSITORY LLC | 091117 | AP (A-rated, therapeutically equivalent) | January 20, 2017 | EQ 10GM BASE/VIAL |
| HIKMA FARMACEUTICA PORTUGAL SA | 090701 | AP (A-rated, therapeutically equivalent) | October 4, 2017 | EQ 10GM BASE/VIAL |
| QILU ANTIBIOTICS PHARMACEUTICAL CO LTD | 209218 | AP (A-rated, therapeutically equivalent) | October 17, 2018 | EQ 10GM BASE/VIAL |
Questions
Is there a generic for Rocephin?
Yes. The generic name for Rocephin is ceftriaxone. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Rocephin?
The active ingredient in Rocephin is ceftriaxone, 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.