FDA Orange Book
Generic for Dotarem
Dotarem contains gadoterate. 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 Dotarem is gadoterate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Dotarem products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 1.8845GM/5ML (376.9MG/ML) | Marketed (Rx) | AP | 2 | AP |
| solution, intravenous | 3.769GM/10ML (376.9MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, intravenous | 37.69GM/100ML (376.9MG/ML) | Marketed (Rx) | AP | 2 | AP |
| solution, intravenous | 5.6535GM/15ML (376.9MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, intravenous | 7.538GM/20ML (376.9MG/ML) | Marketed (Rx) | AP | 3 | AP |
NDA 204781, held by GUERBET LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic gadoterate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GE HEALTHCARE | 210016 | AP (A-rated, therapeutically equivalent) | November 24, 2020 | 1.8845GM/5ML (376.9MG/ML), 3.769GM/10ML (376.9MG/ML), 37.69GM/100ML (376.9MG/ML), 5.6535GM/15ML (376.9MG/ML), 7.538GM/20ML (376.9MG/ML) |
| HAINAN POLY PHARM CO LTD | 218073 | AP (A-rated, therapeutically equivalent) | June 17, 2024 | 1.8845GM/5ML (376.9MG/ML), 3.769GM/10ML (376.9MG/ML), 37.69GM/100ML (376.9MG/ML), 5.6535GM/15ML (376.9MG/ML), 7.538GM/20ML (376.9MG/ML) |
| VIWIT PHARMACEUTICAL CO LTD | 219286 | AP (A-rated, therapeutically equivalent) | August 10, 2026 | 3.769GM/10ML (376.9MG/ML), 5.6535GM/15ML (376.9MG/ML), 7.538GM/20ML (376.9MG/ML) |
Dotarem NDC codes
Questions
Is there a generic for Dotarem?
Yes. The generic name for Dotarem is gadoterate. 3 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 Dotarem?
The active ingredient in Dotarem is gadoterate, 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.