FDA Orange Book
Generic for Levo-dromoran
Levo-dromoran contains levorphanol. 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 Levo-dromoran is levorphanol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 1 of the 2 Levo-dromoran products the Orange Book lists.
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Levo-dromoran products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 2MG | Discontinued | None | 5 | AB, BX |
NDA 008719, 008720, held by VALEANT PHARMACEUTICALS INTERNATIONAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levorphanol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 074278 | AB (A-rated, therapeutically equivalent) | March 31, 2000 | 2MG |
| ACERTIS PHARMACEUTICALS LLC | 211484 | AB (A-rated, therapeutically equivalent) | December 13, 2018 | 2MG |
| SPECGX LLC | 212024 | AB (A-rated, therapeutically equivalent) | December 13, 2019 | 2MG |
| NOVITIUM PHARMA LLC | 213479 | BX (B-rated, not considered equivalent) | July 1, 2020 | 2MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 213906 | AB (A-rated, therapeutically equivalent) | June 17, 2021 | 2MG |
Questions
Is there a generic for Levo-dromoran?
Yes. The generic name for Levo-dromoran is levorphanol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 1 of the 2 Levo-dromoran products the Orange Book lists.
What is the generic name for Levo-dromoran?
The active ingredient in Levo-dromoran is levorphanol, 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.