FDA Orange Book
Generic for Rufen
Rufen contains ibuprofen. 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 Rufen is ibuprofen. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Rufen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 600MG | Discontinued | None | 12 | AB |
NDA 018197, held by BASF CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ibuprofen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CONTRACT PHARMACAL CORP | 071268 | AB (A-rated, therapeutically equivalent) | October 15, 1986 | 600MG |
| AMNEAL PHARMACEUTICALS NY LLC | 071335 | AB (A-rated, therapeutically equivalent) | November 25, 1986 | 600MG |
| DR REDDYS LABORATORIES INC | 076112 | AB (A-rated, therapeutically equivalent) | October 31, 2001 | 600MG |
| DR REDDYS LABORATORIES INC | 075682 | AB (A-rated, therapeutically equivalent) | November 14, 2001 | 600MG |
| AMNEAL PHARMACEUTICALS NY LLC | 078558 | AB (A-rated, therapeutically equivalent) | June 18, 2007 | 600MG |
| STRIDES PHARMA GLOBAL PTE LTD | 078329 | AB (A-rated, therapeutically equivalent) | February 5, 2009 | 600MG |
| PHARMAZONE | 090796 | AB (A-rated, therapeutically equivalent) | December 21, 2010 | 600MG |
| GRANULES INDIA LTD | 091625 | AB (A-rated, therapeutically equivalent) | September 15, 2015 | 600MG |
| SHANDONG XINHUA PHARMACEUTICAL CO LTD | 202413 | AB (A-rated, therapeutically equivalent) | November 23, 2016 | 600MG |
| AUROBINDO PHARMA LTD | 213794 | AB (A-rated, therapeutically equivalent) | May 8, 2020 | 600MG |
| ALKEM LABORATORIES LTD | 214699 | AB (A-rated, therapeutically equivalent) | September 13, 2021 | 600MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 215318 | AB (A-rated, therapeutically equivalent) | March 30, 2022 | 600MG |
Questions
Is there a generic for Rufen?
Yes. The generic name for Rufen is ibuprofen. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Rufen?
The active ingredient in Rufen is ibuprofen, 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.