FDA Orange Book
Generic for Duramorph Pf
Duramorph Pf contains morphine. 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 Duramorph Pf is morphine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Duramorph Pf products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.5MG/ML | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 1MG/ML | Marketed (Rx) | AP | 2 | AP |
NDA 018565, 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 morphine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 073509 | AP (A-rated, therapeutically equivalent) | September 30, 1992 | 0.5MG/ML |
| HOSPIRA INC | 073510 | AP (A-rated, therapeutically equivalent) | September 30, 1992 | 1MG/ML |
| INTERNATIONAL MEDICATION SYSTEMS LTD | 202861 | None (No TE code listed) | April 29, 2021 | 1MG/ML |
Duramorph Pf NDC codes
Questions
Is there a generic for Duramorph Pf?
Yes. The generic name for Duramorph Pf is morphine. 2 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 Duramorph Pf?
The active ingredient in Duramorph Pf is morphine, 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.