FDA Orange Book
Is there a generic for Sprix?
Sprix contains ketorolac. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sprix (ketorolac).
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Sprix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 15.75MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 022382, held by COSETTE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sprix NDC codes
Questions
Is there a generic for Sprix?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sprix (ketorolac).
What is the generic name for Sprix?
The active ingredient in Sprix is ketorolac, 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.
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