FDA Orange Book
Is there a generic for Orabloc?
Orabloc contains articaine and epinephrine. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orabloc (articaine and epinephrine).
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Orabloc products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| injectable, injection | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 022466, held by PIERREL S.P.A.. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Orabloc NDC codes
Questions
Is there a generic for Orabloc?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orabloc (articaine and epinephrine).
What is the generic name for Orabloc?
The active ingredient in Orabloc is articaine and epinephrine, 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.