FDA Orange Book
Generic for Roxicodone
Roxicodone contains oxycodone. 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 Roxicodone is oxycodone. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Roxicodone products the Orange Book lists.
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Roxicodone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 30MG | Discontinued | None | 0 | None |
| tablet, oral | 15MG | Marketed (Rx) | AB | 11 | AB |
| tablet, oral | 30MG | Marketed (Rx) | AB | 11 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 11 | AB |
NDA 020932, 021011, held by ROXANE LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxycodone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SPECGX LLC | 076758 | AB (A-rated, therapeutically equivalent) | June 30, 2004 | 15MG, 30MG, 5MG |
| STRIDES PHARMA INTERNATIONAL AG | 077712 | AB (A-rated, therapeutically equivalent) | January 31, 2007 | 15MG, 30MG, 5MG |
| EPIC PHARMA LLC | 090895 | AB (A-rated, therapeutically equivalent) | August 24, 2009 | 15MG, 30MG, 5MG |
| AVANTHI INC | 091393 | AB (A-rated, therapeutically equivalent) | August 31, 2009 | 15MG, 30MG, 5MG |
| RHODES PHARMACEUTICALS LP | 091490 | AB (A-rated, therapeutically equivalent) | March 9, 2011 | 15MG, 30MG, 5MG |
| ALVOGEN INC | 202116 | AB (A-rated, therapeutically equivalent) | December 30, 2011 | 15MG, 30MG, 5MG |
| AUROLIFE PHARMA LLC | 202160 | AB (A-rated, therapeutically equivalent) | November 19, 2012 | 15MG, 30MG, 5MG |
| AMNEAL PHARMACEUTICALS | 203638 | AB (A-rated, therapeutically equivalent) | June 3, 2014 | 15MG, 30MG, 5MG |
| EPIC PHARMA LLC | 202662 | AB (A-rated, therapeutically equivalent) | September 22, 2015 | 15MG, 30MG, 5MG |
| NUVO PHARMACEUTICAL INC | 207119 | AB (A-rated, therapeutically equivalent) | April 12, 2016 | 15MG, 30MG, 5MG |
| ASCENT PHARMACEUTICALS INC | 207418 | AB (A-rated, therapeutically equivalent) | August 7, 2017 | 15MG, 30MG, 5MG |
Roxicodone NDC codes
Questions
Is there a generic for Roxicodone?
Yes. The generic name for Roxicodone is oxycodone. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Roxicodone products the Orange Book lists.
What is the generic name for Roxicodone?
The active ingredient in Roxicodone is oxycodone, 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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- Is Roxicodone a controlled substance?Schedule II
- What is Oxycodone used for?FDA label uses
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- Schedule II drugs listDEA schedule