FDA Orange Book
Generic for Stadol
Stadol contains butorphanol. 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 Stadol is butorphanol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Stadol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2MG/ML | Discontinued | None | 4 | AP |
| spray, metered, nasal | 1MG/SPRAY | Discontinued | None | 2 | AB |
NDA 017857, 019890, held by APOTHECON INC DIV BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic butorphanol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 074626 | AP (A-rated, therapeutically equivalent) | January 23, 1997 | 2MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 075046 | AP (A-rated, therapeutically equivalent) | August 12, 1998 | 2MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 075045 | AP (A-rated, therapeutically equivalent) | August 12, 1998 | 2MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 075824 | AB (A-rated, therapeutically equivalent) | March 12, 2002 | 1MG/SPRAY |
| APOTEX INC | 075499 | AB (A-rated, therapeutically equivalent) | December 4, 2002 | 1MG/SPRAY |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 078400 | AP (A-rated, therapeutically equivalent) | May 1, 2009 | 2MG/ML |
Questions
Is there a generic for Stadol?
Yes. The generic name for Stadol is butorphanol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Stadol?
The active ingredient in Stadol is butorphanol, 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.