FDA Orange Book
Generic for Dobutrex
Dobutrex contains dobutamine. 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 Dobutrex is dobutamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Dobutrex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 12.5MG BASE/ML | Discontinued | None | 3 | AP |
NDA 017820, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dobutamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 074086 | AP (A-rated, therapeutically equivalent) | November 29, 1993 | EQ 12.5MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 074277 | AP (A-rated, therapeutically equivalent) | October 31, 1994 | EQ 12.5MG BASE/ML |
| HAINAN POLY PHARM CO LTD | 216131 | AP (A-rated, therapeutically equivalent) | December 21, 2022 | EQ 12.5MG BASE/ML |
Questions
Is there a generic for Dobutrex?
Yes. The generic name for Dobutrex is dobutamine. 3 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 Dobutrex?
The active ingredient in Dobutrex is dobutamine, 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.