FDA Orange Book
Generic for Azactam
Azactam contains aztreonam. 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 Azactam is aztreonam. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Azactam products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1GM/VIAL | Marketed (Rx) | AP | 2 | AP |
| injectable, injection | 2GM/VIAL | Marketed (Rx) | AP | 2 | AP |
| injectable, injection | 500MG/VIAL | Discontinued | None | 1 | None |
NDA 050580, held by LABORATOIRES DELBERT. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic aztreonam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 065439 | AP (A-rated, therapeutically equivalent) | June 18, 2010 | 1GM/VIAL, 2GM/VIAL, 500MG/VIAL |
| HOSPIRA INC | 206517 | AP (A-rated, therapeutically equivalent) | November 8, 2021 | 1GM/VIAL, 2GM/VIAL |
Azactam NDC codes
Questions
Is there a generic for Azactam?
Yes. The generic name for Azactam is aztreonam. 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 Azactam?
The active ingredient in Azactam is aztreonam, 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.