FDA Orange Book
Generic for Aloxi
Aloxi contains palonosetron. 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 Aloxi is palonosetron. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Aloxi products the Orange Book lists.
Run it in Rivvi
Map Aloxi 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.
Aloxi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.5MG BASE | Discontinued | None | 0 | None |
| injectable, intravenous | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | Discontinued | None | 1 | None |
| injectable, intravenous | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | Discontinued | None | 14 | AP |
NDA 022233, 021372, held by HELSINN HEALTHCARE SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic palonosetron
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 202521 | AP (A-rated, therapeutically equivalent) | October 13, 2015 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| DR REDDYS LABORATORIES LTD | 201533 | AP (A-rated, therapeutically equivalent) | April 21, 2016 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| TEVA PHARMACEUTICALS USA | 090713 | AP (A-rated, therapeutically equivalent) | March 23, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| CHARTWELL RX SCIENCES LLC | 209287 | AP (A-rated, therapeutically equivalent) | September 19, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| FRESENIUS KABI USA LLC | 206801 | AP (A-rated, therapeutically equivalent) | September 19, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| FRESENIUS KABI USA LLC | 206802 | AP (A-rated, therapeutically equivalent) | September 19, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| HOSPIRA INC | 207005 | AP (A-rated, therapeutically equivalent) | September 19, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| MYLAN INSTITUTIONAL LLC | 206416 | AP (A-rated, therapeutically equivalent) | September 19, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| QILU PHARMACEUTICAL HAINAN CO LTD | 205648 | AP (A-rated, therapeutically equivalent) | September 19, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| SAGENT PHARMACEUTICALS INC | 204289 | AP (A-rated, therapeutically equivalent) | September 19, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| SAGENT PHARMACEUTICALS INC | 205870 | AP (A-rated, therapeutically equivalent) | September 19, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 204702 | AP (A-rated, therapeutically equivalent) | November 6, 2018 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| AVET LIFESCIENCES LTD | 202951 | None (No TE code listed) | June 29, 2021 | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML), EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| MEITHEAL PHARMACEUTICALS INC | 215861 | AP (A-rated, therapeutically equivalent) | August 14, 2023 | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
Aloxi NDC codes
Questions
Is there a generic for Aloxi?
Yes. The generic name for Aloxi is palonosetron. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Aloxi products the Orange Book lists.
What is the generic name for Aloxi?
The active ingredient in Aloxi is palonosetron, 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.