FDA Orange Book
Is there a generic for Septocaine?
Septocaine 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 Septocaine (articaine and epinephrine).
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Septocaine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| injectable, injection | 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 020971, held by DEPROCO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Septocaine NDC codes
Questions
Is there a generic for Septocaine?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Septocaine (articaine and epinephrine).
What is the generic name for Septocaine?
The active ingredient in Septocaine 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.