FDA Orange Book
Generic for Romazicon
Romazicon contains flumazenil. 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 Romazicon is flumazenil. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Romazicon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.5MG/5ML (0.1MG/ML) | Discontinued | None | 7 | AP |
| injectable, injection | 1MG/10ML (0.1MG/ML) | Discontinued | None | 6 | AP |
NDA 020073, 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 flumazenil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAXTER HEALTHCARE CORP | 076755 | AP (A-rated, therapeutically equivalent) | October 12, 2004 | 0.5MG/5ML (0.1MG/ML), 1MG/10ML (0.1MG/ML) |
| FRESENIUS KABI USA LLC | 076955 | AP (A-rated, therapeutically equivalent) | October 12, 2004 | 0.5MG/5ML (0.1MG/ML), 1MG/10ML (0.1MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 076256 | AP (A-rated, therapeutically equivalent) | October 12, 2004 | 0.5MG/5ML (0.1MG/ML), 1MG/10ML (0.1MG/ML) |
| SANDOZ INC | 077071 | AP (A-rated, therapeutically equivalent) | May 3, 2005 | 0.5MG/5ML (0.1MG/ML), 1MG/10ML (0.1MG/ML) |
| RISING PHARMA HOLDING INC | 078595 | AP (A-rated, therapeutically equivalent) | May 13, 2008 | 0.5MG/5ML (0.1MG/ML) |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 078527 | AP (A-rated, therapeutically equivalent) | March 23, 2009 | 0.5MG/5ML (0.1MG/ML), 1MG/10ML (0.1MG/ML) |
| SAGENT PHARMACEUTICALS INC | 090584 | AP (A-rated, therapeutically equivalent) | August 28, 2012 | 0.5MG/5ML (0.1MG/ML), 1MG/10ML (0.1MG/ML) |
Questions
Is there a generic for Romazicon?
Yes. The generic name for Romazicon is flumazenil. 7 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 Romazicon?
The active ingredient in Romazicon is flumazenil, 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.