FDA Orange Book
Generic for Oramorph SR
Oramorph SR contains morphine. 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 Oramorph SR is morphine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Oramorph SR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 100MG | Discontinued | None | 3 | AB |
| tablet, extended release, oral | 15MG | Discontinued | None | 4 | AB |
| tablet, extended release, oral | 30MG | Discontinued | None | 3 | AB |
| tablet, extended release, oral | 60MG | Discontinued | None | 3 | AB |
NDA 019977, held by XANODYNE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic morphine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RHODES PHARMACEUTICALS LP | 074769 | AB (A-rated, therapeutically equivalent) | July 2, 1998 | 100MG |
| RHODES PHARMACEUTICALS LP | 074862 | AB (A-rated, therapeutically equivalent) | July 7, 1998 | 15MG, 30MG, 60MG |
| DAVA PHARMACEUTICALS INC | 075407 | AB (A-rated, therapeutically equivalent) | January 28, 2000 | 15MG |
| SPECGX LLC | 076438 | AB (A-rated, therapeutically equivalent) | July 3, 2003 | 100MG |
| SPECGX LLC | 076412 | AB (A-rated, therapeutically equivalent) | July 31, 2003 | 15MG, 30MG, 60MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 078761 | AB (A-rated, therapeutically equivalent) | May 11, 2012 | 100MG, 15MG, 30MG, 60MG |
Questions
Is there a generic for Oramorph SR?
Yes. The generic name for Oramorph SR is morphine. 4 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 Oramorph SR?
The active ingredient in Oramorph SR is morphine, 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.