FDA Orange Book
Generic for Tham
Tham contains tromethamine. 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 Tham is tromethamine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Tham products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, injection | 18GM/500ML (3.6GM/100ML) | Marketed (Rx) | AP | 2 | AP |
NDA 013025, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tromethamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| B BRAUN MEDICAL INC | 211558 | AP (A-rated, therapeutically equivalent) | December 9, 2024 | 18GM/500ML (3.6GM/100ML) |
| MILLA PHARMACEUTICALS INC | 213116 | AP (A-rated, therapeutically equivalent) | December 31, 2024 | 18GM/500ML (3.6GM/100ML) |
Tham NDC codes
Questions
Is there a generic for Tham?
Yes. The generic name for Tham is tromethamine. 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 Tham?
The active ingredient in Tham is tromethamine, 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.