FDA Orange Book
Generic for Motrin
Motrin 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 Motrin is ibuprofen. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 9 Motrin products the Orange Book lists.
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Motrin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, oral | 40MG/ML | Discontinued | None | 0 | None |
| suspension, oral | 100MG/5ML | Discontinued | None | 5 | AB |
| tablet, chewable, oral | 100MG | Discontinued | None | 0 | None |
| tablet, chewable, oral | 50MG | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Discontinued | None | 0 | None |
| tablet, oral | 300MG | Discontinued | None | 1 | None |
| tablet, oral | 400MG | Discontinued | None | 12 | AB |
| tablet, oral | 600MG | Discontinued | None | 12 | AB |
| tablet, oral | 800MG | Discontinued | None | 12 | AB |
NDA 020476, 019842, 020135, 020418, 017463, held by MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC. 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 | 400MG, 600MG, 800MG |
| AMNEAL PHARMACEUTICALS NY LLC | 071334 | AB (A-rated, therapeutically equivalent) | November 25, 1986 | 400MG |
| AMNEAL PHARMACEUTICALS NY LLC | 071335 | AB (A-rated, therapeutically equivalent) | November 25, 1986 | 600MG |
| AMNEAL PHARMACEUTICALS NY LLC | 071935 | AB (A-rated, therapeutically equivalent) | October 13, 1987 | 800MG |
| ACTAVIS MID ATLANTIC LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 074978 | AB (A-rated, therapeutically equivalent) | March 25, 1998 | 100MG/5ML |
| DR REDDYS LABORATORIES INC | 076112 | AB (A-rated, therapeutically equivalent) | October 31, 2001 | 400MG, 600MG, 800MG |
| DR REDDYS LABORATORIES INC | 075682 | AB (A-rated, therapeutically equivalent) | November 14, 2001 | 400MG, 600MG, 800MG |
| PADAGIS US LLC | 076925 | AB (A-rated, therapeutically equivalent) | September 23, 2004 | 100MG/5ML |
| AMNEAL PHARMACEUTICALS NY LLC | 078558 | AB (A-rated, therapeutically equivalent) | June 18, 2007 | 400MG, 600MG, 800MG |
| STRIDES PHARMA GLOBAL PTE LTD | 078329 | AB (A-rated, therapeutically equivalent) | February 5, 2009 | 400MG, 600MG, 800MG |
| PHARMAZONE | 090796 | AB (A-rated, therapeutically equivalent) | December 21, 2010 | 400MG, 600MG, 800MG |
| GRANULES INDIA LTD | 091625 | AB (A-rated, therapeutically equivalent) | September 15, 2015 | 400MG, 600MG, 800MG |
| SUN PHARMA CANADA INC | 209204 | AB (A-rated, therapeutically equivalent) | June 23, 2017 | 100MG/5ML |
| AUROBINDO PHARMA LTD | 209178 | AB (A-rated, therapeutically equivalent) | February 16, 2018 | 100MG/5ML |
| AUROBINDO PHARMA LTD | 213794 | AB (A-rated, therapeutically equivalent) | May 8, 2020 | 400MG, 600MG, 800MG |
| ALKEM LABORATORIES LTD | 214699 | AB (A-rated, therapeutically equivalent) | September 13, 2021 | 400MG, 600MG, 800MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 215318 | AB (A-rated, therapeutically equivalent) | March 30, 2022 | 400MG, 600MG, 800MG |
| STRIDES PHARMA GLOBAL PTE LTD | 215311 | AB (A-rated, therapeutically equivalent) | May 27, 2022 | 100MG/5ML |
| SHANDONG XINHUA PHARMACEUTICAL CO LTD | 202413 | None (No TE code listed) | July 5, 2024 | 300MG, 400MG, 600MG, 800MG |
Questions
Is there a generic for Motrin?
Yes. The generic name for Motrin is ibuprofen. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 9 Motrin products the Orange Book lists.
What is the generic name for Motrin?
The active ingredient in Motrin 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.