FDA Orange Book
Generic for Xylocaine
Xylocaine 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 is lidocaine. 30 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP, AT. Generics match 9 of the 12 Xylocaine products the Orange Book lists.
Run it in Rivvi
Map Xylocaine and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Xylocaine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, oral | 10% | Discontinued | None | 0 | None |
| injectable, injection | 0.5% | Marketed (Rx) | AP | 2 | AP |
| injectable, injection | 1% | Marketed (Rx) | AP | 23 | AP |
| injectable, injection | 1% | Discontinued | None | 23 | AP |
| injectable, injection | 1.5% | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 1.5% | Discontinued | None | 1 | AP |
| injectable, injection | 2% | Marketed (Rx) | AP | 18 | AP |
| injectable, injection | 2% | Discontinued | None | 18 | AP |
| jelly, topical | 2% | Discontinued | None | 3 | AT |
| ointment, topical | 5% | Discontinued | None | 13 | AT |
| solution, topical | 5% | Discontinued | None | 0 | None |
| suppository, rectal | 100MG | Discontinued | None | 0 | None |
NDA 014394, 006488, 010418, 008816, 008048, 014127, 013077, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 088328 | AP (A-rated, therapeutically equivalent) | May 17, 1984 | 0.5% |
| HOSPIRA INC | 088329 | AP (A-rated, therapeutically equivalent) | May 17, 1984 | 1%, 1% |
| HOSPIRA INC | 088294 | AP (A-rated, therapeutically equivalent) | May 17, 1984 | 2%, 2% |
| HOSPIRA INC | 088325 | AP (A-rated, therapeutically equivalent) | July 31, 1984 | 0.5% |
| HOSPIRA INC | 088299 | AP (A-rated, therapeutically equivalent) | July 31, 1984 | 1%, 1% |
| HOSPIRA INC | 088327 | AP (A-rated, therapeutically equivalent) | July 31, 1984 | 2%, 2% |
| HOSPIRA INC | 040078 | AP (A-rated, therapeutically equivalent) | June 23, 1995 | 2%, 2% |
| HOSPIRA INC | 040302 | AP (A-rated, therapeutically equivalent) | September 28, 1998 | 1%, 1%, 2%, 2% |
| SENTISS AG | 040433 | AT (A-rated, therapeutically equivalent) | February 12, 2003 | 2% |
| SEPTODONT INC | 040911 | AT (A-rated, therapeutically equivalent) | May 23, 2011 | 5% |
| EUGIA PHARMA SPECIALITIES LTD | 203082 | AP (A-rated, therapeutically equivalent) | March 14, 2013 | 1%, 1%, 2%, 2% |
| SAGENT PHARMACEUTICALS INC | 201094 | AT (A-rated, therapeutically equivalent) | April 28, 2014 | 2% |
| AMNEAL PHARMACEUTICALS | 206297 | AT (A-rated, therapeutically equivalent) | August 7, 2015 | 5% |
| ENCUBE ETHICALS PRIVATE LTD | 205318 | AT (A-rated, therapeutically equivalent) | February 1, 2016 | 5% |
| GLENMARK PHARMACEUTICALS LTD | 206498 | AT (A-rated, therapeutically equivalent) | September 9, 2016 | 5% |
| ALKEM LABORATORIES LTD | 207810 | AT (A-rated, therapeutically equivalent) | March 10, 2017 | 5% |
| EUGIA PHARMA SPECIALITIES LTD | 207182 | AP (A-rated, therapeutically equivalent) | October 30, 2017 | 1%, 1%, 2%, 2% |
| SPECTRA MEDICAL DEVICES INC | 208017 | AP (A-rated, therapeutically equivalent) | April 18, 2018 | 1%, 1% |
| B BRAUN MEDICAL INC | 208474 | AP (A-rated, therapeutically equivalent) | August 3, 2018 | 1%, 1% |
| ALEMBIC PHARMACEUTICALS LTD | 211469 | AT (A-rated, therapeutically equivalent) | November 23, 2018 | 5% |
| STRIDES PHARMA GLOBAL PTE LTD | 210958 | AT (A-rated, therapeutically equivalent) | December 11, 2018 | 5% |
| MACLEODS PHARMACEUTICALS LTD | 211697 | AT (A-rated, therapeutically equivalent) | March 16, 2020 | 5% |
| HUONS CO LTD | 212821 | AP (A-rated, therapeutically equivalent) | May 7, 2020 | 1%, 1%, 2%, 2% |
| CHARTWELL RX SCIENCES LLC | 208660 | AT (A-rated, therapeutically equivalent) | January 5, 2021 | 5% |
| QUAGEN PHARMACEUTICALS LLC | 212695 | AT (A-rated, therapeutically equivalent) | April 20, 2021 | 5% |
| ASPIRO PHARMA LTD | 214336 | AP (A-rated, therapeutically equivalent) | November 8, 2021 | 1%, 1%, 2%, 2% |
| ASPIRO PHARMA LTD | 214339 | AP (A-rated, therapeutically equivalent) | November 8, 2021 | 1%, 1%, 2%, 2% |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 215132 | AP (A-rated, therapeutically equivalent) | June 9, 2022 | 1%, 1% |
| PHARMOBEDIENT CONSULTING LLC | 214267 | AP (A-rated, therapeutically equivalent) | September 19, 2022 | 1%, 1%, 2%, 2% |
| MANKIND PHARMA LTD | 217692 | AP (A-rated, therapeutically equivalent) | June 16, 2023 | 1%, 1%, 1%, 1%, 2%, 2% |
| MANKIND PHARMA LTD | 217693 | AP (A-rated, therapeutically equivalent) | July 11, 2023 | 1%, 1%, 2%, 2% |
| AUROBINDO PHARMA LTD | 217117 | AT (A-rated, therapeutically equivalent) | June 18, 2024 | 5% |
| ADAPTIS PHARMA PRIVATE LTD | 219535 | AP (A-rated, therapeutically equivalent) | April 2, 2025 | 1%, 1%, 2%, 2% |
| VIWIT PHARMACEUTICAL CO LTD | 220071 | AP (A-rated, therapeutically equivalent) | March 19, 2026 | 1%, 1%, 2%, 2% |
| FRESENIUS KABI USA LLC | 088586 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 1%, 1%, 1%, 2%, 2% |
| INTERNATIONAL MEDICATION SYSTEM | 083173 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 1%, 2%, 2% |
| WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 080407 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 1%, 2%, 2% |
| HIKMA PHARMACEUTICALS USA INC | 084625 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 1%, 2%, 2% |
| HOSPIRA INC | 080408 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1%, 1%, 1.5%, 1.5% |
| INTERNATIONAL MEDICATION SYSTEM | 086283 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 2% |
| FOUGERA PHARMACEUTICALS INC | 080198 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5% |
| SUN PHARMA CANADA INC | 086724 | AT (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5% |
Xylocaine NDC codes
Questions
Is there a generic for Xylocaine?
Yes. The generic name for Xylocaine is lidocaine. 30 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP, AT. Generics match 9 of the 12 Xylocaine products the Orange Book lists.
What is the generic name for Xylocaine?
The active ingredient in Xylocaine 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.
More on Xylocaine and Lidocaine
- What is Lidocaine used for?FDA label uses
- Is Lidocaine a controlled substance?Federal schedule
- Generic for AktenFDA Orange Book
- Generic for Xylocaine DentalFDA Orange Book
- Generic for Xylocaine Preservative FreeFDA Orange Book
- Generic for LidodermFDA Orange Book
- Generic for ZtlidoFDA Orange Book
- Generic for Xylocaine ViscousFDA Orange Book
- Generic for BondlidoFDA Orange Book
- Amide Local Anesthetics listFDA drug class
- Antiarrhythmics listFDA drug class
- NDC 0404-9973Xylocaine NDC record
- NDC 0404-9974Xylocaine NDC record
- NDC 63323-484Xylocaine NDC record