FDA Orange Book
Generic for Dopram
Dopram contains doxapram. 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 Dopram is doxapram. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Dopram products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 20MG/ML | Marketed (Rx) | AP | 1 | AP |
NDA 014879, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxapram
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL INJECTABLES LLC | 076266 | AP (A-rated, therapeutically equivalent) | January 10, 2003 | 20MG/ML |
Dopram NDC codes
Questions
Is there a generic for Dopram?
Yes. The generic name for Dopram is doxapram. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Dopram?
The active ingredient in Dopram is doxapram, 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.