FDA Orange Book
Generic for Sufenta Preservative Free
Sufenta Preservative Free contains sufentanil. 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 Sufenta Preservative Free is sufentanil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Sufenta Preservative Free products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 0.05MG BASE/ML | Marketed (Rx) | AP | 1 | AP |
NDA 019050, held by RISING PHARMA HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sufentanil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 074534 | AP (A-rated, therapeutically equivalent) | December 11, 1996 | EQ 0.05MG BASE/ML |
Questions
Is there a generic for Sufenta Preservative Free?
Yes. The generic name for Sufenta Preservative Free is sufentanil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Sufenta Preservative Free?
The active ingredient in Sufenta Preservative Free is sufentanil, 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.