FDA Orange Book
Generic for Nesacaine
Nesacaine contains chloroprocaine. 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 Nesacaine is chloroprocaine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Nesacaine products the Orange Book lists.
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Nesacaine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1% | Discontinued | None | 0 | None |
| injectable, injection | 2% | Marketed (Rx) | AP | 1 | AP |
NDA 009435, 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 chloroprocaine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 040273 | AP (A-rated, therapeutically equivalent) | September 9, 1998 | 2% |
Nesacaine NDC codes
Questions
Is there a generic for Nesacaine?
Yes. The generic name for Nesacaine is chloroprocaine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Nesacaine products the Orange Book lists.
What is the generic name for Nesacaine?
The active ingredient in Nesacaine is chloroprocaine, 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.