FDA Orange Book
Generic for Xylocaine Dental
Xylocaine Dental contains lidocaine. 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 Dental is lidocaine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Xylocaine Dental products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2% | Discontinued | None | 18 | AP |
NDA 021380, held by DENTSPLY PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lidocaine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 088294 | AP (A-rated, therapeutically equivalent) | May 17, 1984 | 2% |
| HOSPIRA INC | 088327 | AP (A-rated, therapeutically equivalent) | July 31, 1984 | 2% |
| HOSPIRA INC | 040078 | AP (A-rated, therapeutically equivalent) | June 23, 1995 | 2% |
| HOSPIRA INC | 040302 | AP (A-rated, therapeutically equivalent) | September 28, 1998 | 2% |
| EUGIA PHARMA SPECIALITIES LTD | 203082 | AP (A-rated, therapeutically equivalent) | March 14, 2013 | 2% |
| EUGIA PHARMA SPECIALITIES LTD | 207182 | AP (A-rated, therapeutically equivalent) | October 30, 2017 | 2% |
| ASPIRO PHARMA LTD | 214339 | AP (A-rated, therapeutically equivalent) | November 8, 2021 | 2% |
| PHARMOBEDIENT CONSULTING LLC | 214267 | AP (A-rated, therapeutically equivalent) | September 19, 2022 | 2% |
| HUONS CO LTD | 212821 | AP (A-rated, therapeutically equivalent) | June 15, 2023 | 2% |
| MANKIND PHARMA LTD | 217692 | AP (A-rated, therapeutically equivalent) | June 16, 2023 | 2% |
| MANKIND PHARMA LTD | 217693 | AP (A-rated, therapeutically equivalent) | July 11, 2023 | 2% |
| ASPIRO PHARMA LTD | 214336 | AP (A-rated, therapeutically equivalent) | December 13, 2023 | 2% |
| ADAPTIS PHARMA PRIVATE LTD | 219535 | AP (A-rated, therapeutically equivalent) | February 6, 2026 | 2% |
| VIWIT PHARMACEUTICAL CO LTD | 220071 | AP (A-rated, therapeutically equivalent) | March 19, 2026 | 2% |
| FRESENIUS KABI USA LLC | 088586 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 2% |
| INTERNATIONAL MEDICATION SYSTEM | 083173 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 2% |
| WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 080407 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 2% |
| HIKMA PHARMACEUTICALS USA INC | 084625 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 2% |
Questions
Is there a generic for Xylocaine Dental?
Yes. The generic name for Xylocaine Dental is lidocaine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Xylocaine Dental?
The active ingredient in Xylocaine Dental is lidocaine, 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.