FDA Orange Book
Generic for NebuPent
NebuPent contains pentamidine isethionate. 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 NebuPent is pentamidine isethionate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN. Generics match 1 of the 2 NebuPent products the Orange Book lists.
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NebuPent products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, inhalation | 300MG/VIAL | Marketed (Rx) | AN | 2 | AN |
| for solution, inhalation | 600MG/VIAL | Discontinued | None | 0 | None |
NDA 019887, held by FRESENIUS KABI USA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pentamidine isethionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA | 206667 | AN (A-rated, therapeutically equivalent) | April 24, 2019 | 300MG/VIAL |
| X-GEN PHARMACEUTICALS INC | 206983 | AN (A-rated, therapeutically equivalent) | January 20, 2023 | 300MG/VIAL |
NebuPent NDC codes
Questions
Is there a generic for NebuPent?
Yes. The generic name for NebuPent is pentamidine isethionate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN. Generics match 1 of the 2 NebuPent products the Orange Book lists.
What is the generic name for NebuPent?
The active ingredient in NebuPent is pentamidine isethionate, 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.