FDA Orange Book
Generic for Xylocaine W/ Epinephrine
Xylocaine W/ Epinephrine contains lidocaine 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
Yes. The generic name for Xylocaine W/ Epinephrine is lidocaine and epinephrine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 7 of the 10 Xylocaine W/ Epinephrine products the Orange Book lists.
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Xylocaine W/ Epinephrine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.005MG/ML;0.5% | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 0.005MG/ML;1% | Marketed (Rx) | None | 0 | None |
| injectable, injection | 0.005MG/ML;1% | Discontinued | None | 0 | None |
| injectable, injection | 0.005MG/ML;1.5% | Marketed (Rx) | AP | 3 | AP |
| injectable, injection | 0.005MG/ML;1.5% | Discontinued | None | 3 | AP |
| injectable, injection | 0.005MG/ML;2% | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 0.005MG/ML;2% | Discontinued | None | 1 | AP |
| injectable, injection | 0.01MG/ML;1% | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 0.01MG/ML;2% | Discontinued | None | 1 | None |
| injectable, injection | 0.02MG/ML;2% | Marketed (Rx) | None | 0 | None |
NDA 006488, 010418, held by ASTRAZENECA LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lidocaine and epinephrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 088571 | AP (A-rated, therapeutically equivalent) | September 13, 1985 | 0.005MG/ML;1.5%, 0.005MG/ML;1.5% |
| HOSPIRA INC | 089635 | AP (A-rated, therapeutically equivalent) | June 21, 1988 | 0.005MG/ML;0.5% |
| HOSPIRA INC | 089645 | AP (A-rated, therapeutically equivalent) | June 21, 1988 | 0.005MG/ML;1.5%, 0.005MG/ML;1.5% |
| HOSPIRA INC | 089651 | AP (A-rated, therapeutically equivalent) | June 21, 1988 | 0.005MG/ML;2%, 0.005MG/ML;2% |
| HOSPIRA INC | 089644 | AP (A-rated, therapeutically equivalent) | June 21, 1988 | 0.01MG/ML;1% |
| HOSPIRA INC | 089646 | None (No TE code listed) | June 21, 1988 | 0.01MG/ML;2% |
| B BRAUN MEDICAL INC | 208475 | AP (A-rated, therapeutically equivalent) | September 8, 2021 | 0.005MG/ML;1.5%, 0.005MG/ML;1.5% |
Xylocaine W/ Epinephrine NDC codes
Questions
Is there a generic for Xylocaine W/ Epinephrine?
Yes. The generic name for Xylocaine W/ Epinephrine is lidocaine and epinephrine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 7 of the 10 Xylocaine W/ Epinephrine products the Orange Book lists.
What is the generic name for Xylocaine W/ Epinephrine?
The active ingredient in Xylocaine W/ Epinephrine is lidocaine 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.