FDA Orange Book
Generic for Emla
Emla contains lidocaine and prilocaine. 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 Emla is lidocaine and prilocaine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Emla products the Orange Book lists.
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Emla products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 2.5%;2.5% | Discontinued | None | 5 | AB |
| disc, topical | 2.5%;2.5% | Discontinued | None | 0 | None |
NDA 019941, 020962, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lidocaine and prilocaine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 076453 | AB (A-rated, therapeutically equivalent) | August 18, 2003 | 2.5%;2.5% |
| ENCUBE ETHICALS PRIVATE LTD | 076320 | AB (A-rated, therapeutically equivalent) | August 27, 2003 | 2.5%;2.5% |
| PADAGIS US LLC | 212482 | AB (A-rated, therapeutically equivalent) | July 27, 2021 | 2.5%;2.5% |
| ALEMBIC PHARMACEUTICALS LTD | 213923 | AB (A-rated, therapeutically equivalent) | April 8, 2022 | 2.5%;2.5% |
| ZYDUS LIFESCIENCES LTD | 219120 | AB (A-rated, therapeutically equivalent) | December 17, 2024 | 2.5%;2.5% |
Questions
Is there a generic for Emla?
Yes. The generic name for Emla is lidocaine and prilocaine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Emla products the Orange Book lists.
What is the generic name for Emla?
The active ingredient in Emla is lidocaine and prilocaine, 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.