FDA Orange Book
Generic for Luvox
Luvox contains fluvoxamine. 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 Luvox is fluvoxamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Luvox products the Orange Book lists.
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Luvox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 100MG | Discontinued | None | 3 | AB |
| tablet, oral | 150MG | Discontinued | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 25MG | Discontinued | None | 3 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 50MG | Discontinued | None | 3 | AB |
NDA 021519, 020243, held by ANI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluvoxamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AIPING PHARMACEUTICAL INC | 075888 | AB (A-rated, therapeutically equivalent) | November 29, 2000 | 100MG, 100MG, 25MG, 25MG, 50MG, 50MG |
| APOTEX INC | 075902 | AB (A-rated, therapeutically equivalent) | May 7, 2001 | 100MG, 100MG, 25MG, 25MG, 50MG, 50MG |
| BIONPHARMA INC | 217917 | AB (A-rated, therapeutically equivalent) | January 22, 2024 | 100MG, 100MG, 25MG, 25MG, 50MG, 50MG |
Luvox NDC codes
Questions
Is there a generic for Luvox?
Yes. The generic name for Luvox is fluvoxamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Luvox products the Orange Book lists.
What is the generic name for Luvox?
The active ingredient in Luvox is fluvoxamine, 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.