FDA Orange Book
Generic for Pentam
Pentam 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 Pentam is pentamidine isethionate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Pentam and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Pentam products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 300MG/VIAL | Marketed (Rx) | AP | 2 | AP |
NDA 019264, 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 | 206666 | AP (A-rated, therapeutically equivalent) | September 28, 2017 | 300MG/VIAL |
| AVET LIFESCIENCES LTD | 213806 | AP (A-rated, therapeutically equivalent) | January 7, 2021 | 300MG/VIAL |
Pentam NDC codes
Questions
Is there a generic for Pentam?
Yes. The generic name for Pentam is pentamidine isethionate. 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 Pentam?
The active ingredient in Pentam 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.