FDA Orange Book
Generic for Sublimaze Preservative Free
Sublimaze Preservative Free contains fentanyl. 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 Sublimaze Preservative Free is fentanyl. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Sublimaze 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 | 2 | AP |
NDA 016619, 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 fentanyl
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 210762 | AP (A-rated, therapeutically equivalent) | May 3, 2019 | EQ 0.05MG BASE/ML |
| FRESENIUS KABI USA LLC | 212086 | AP (A-rated, therapeutically equivalent) | September 1, 2020 | EQ 0.05MG BASE/ML |
Questions
Is there a generic for Sublimaze Preservative Free?
Yes. The generic name for Sublimaze Preservative Free is fentanyl. 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 Sublimaze Preservative Free?
The active ingredient in Sublimaze Preservative Free is fentanyl, 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.