FDA Orange Book
Generic for Xylocaine Preservative Free
Xylocaine Preservative Free 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 Preservative Free is lidocaine. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 5 Xylocaine Preservative Free products the Orange Book lists.
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Xylocaine Preservative Free products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1% | Discontinued | None | 23 | AP |
| injectable, injection | 10% | Discontinued | None | 0 | None |
| injectable, injection | 2% | Discontinued | None | 18 | AP |
| injectable, injection | 20% | Discontinued | None | 0 | None |
| injectable, injection | 4% | Discontinued | None | 2 | AP |
NDA 016801, held by FRESENIUS KABI USA LLC. 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 | 088329 | AP (A-rated, therapeutically equivalent) | May 17, 1984 | 1% |
| HOSPIRA INC | 088294 | AP (A-rated, therapeutically equivalent) | May 17, 1984 | 2% |
| HOSPIRA INC | 088295 | AP (A-rated, therapeutically equivalent) | May 17, 1984 | 4% |
| HOSPIRA INC | 088299 | AP (A-rated, therapeutically equivalent) | July 31, 1984 | 1% |
| 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 | 1%, 2% |
| EUGIA PHARMA SPECIALITIES LTD | 203082 | AP (A-rated, therapeutically equivalent) | March 14, 2013 | 1%, 2% |
| EUGIA PHARMA SPECIALITIES LTD | 207182 | AP (A-rated, therapeutically equivalent) | October 30, 2017 | 1%, 2% |
| SPECTRA MEDICAL DEVICES INC | 208017 | AP (A-rated, therapeutically equivalent) | April 18, 2018 | 1% |
| B BRAUN MEDICAL INC | 208474 | AP (A-rated, therapeutically equivalent) | August 3, 2018 | 1% |
| HUONS CO LTD | 212821 | AP (A-rated, therapeutically equivalent) | May 7, 2020 | 1%, 2% |
| ASPIRO PHARMA LTD | 214336 | AP (A-rated, therapeutically equivalent) | November 8, 2021 | 1%, 2% |
| ASPIRO PHARMA LTD | 214339 | AP (A-rated, therapeutically equivalent) | November 8, 2021 | 1%, 2% |
| PHARMOBEDIENT CONSULTING LLC | 214269 | AP (A-rated, therapeutically equivalent) | May 5, 2022 | 4% |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 215132 | AP (A-rated, therapeutically equivalent) | June 9, 2022 | 1% |
| PHARMOBEDIENT CONSULTING LLC | 214267 | AP (A-rated, therapeutically equivalent) | September 19, 2022 | 1%, 2% |
| MANKIND PHARMA LTD | 217692 | AP (A-rated, therapeutically equivalent) | June 16, 2023 | 1%, 1%, 2% |
| MANKIND PHARMA LTD | 217693 | AP (A-rated, therapeutically equivalent) | July 11, 2023 | 1%, 2% |
| ADAPTIS PHARMA PRIVATE LTD | 219535 | AP (A-rated, therapeutically equivalent) | April 2, 2025 | 1%, 2% |
| VIWIT PHARMACEUTICAL CO LTD | 220071 | AP (A-rated, therapeutically equivalent) | March 19, 2026 | 1%, 2% |
| FRESENIUS KABI USA LLC | 088586 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 1%, 2% |
| INTERNATIONAL MEDICATION SYSTEM | 083173 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 2% |
| WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 080407 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 2% |
| HIKMA PHARMACEUTICALS USA INC | 084625 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 2% |
| HOSPIRA INC | 080408 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1% |
Questions
Is there a generic for Xylocaine Preservative Free?
Yes. The generic name for Xylocaine Preservative Free is lidocaine. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 5 Xylocaine Preservative Free products the Orange Book lists.
What is the generic name for Xylocaine Preservative Free?
The active ingredient in Xylocaine Preservative Free 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.