FDA Orange Book
Generic for D.h.e.
D.h.e. contains dihydroergotamine. 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 D.h.e. is dihydroergotamine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map D.h.e. and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
D.h.e. products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1MG/ML | Discontinued | None | 5 | AP |
NDA 005929, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dihydroergotamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 040453 | AP (A-rated, therapeutically equivalent) | June 9, 2003 | 1MG/ML |
| HIKMA PHARMACEUTICALS | 206621 | AP (A-rated, therapeutically equivalent) | September 15, 2017 | 1MG/ML |
| SAGENT PHARMACEUTICALS INC | 207264 | AP (A-rated, therapeutically equivalent) | July 11, 2018 | 1MG/ML |
| MILLA PHARMACEUTICALS INC | 212046 | AP (A-rated, therapeutically equivalent) | January 7, 2020 | 1MG/ML |
| GLAND PHARMA LTD | 215623 | AP (A-rated, therapeutically equivalent) | August 18, 2023 | 1MG/ML |
Questions
Is there a generic for D.h.e.?
Yes. The generic name for D.h.e. is dihydroergotamine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for D.h.e.?
The active ingredient in D.h.e. is dihydroergotamine, 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.