FDA Orange Book

Is there a generic for Ultravist (pharmacy Bulk)?

Ultravist (pharmacy Bulk) contains iopromide. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Ultravist (pharmacy Bulk) (iopromide).

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Ultravist (pharmacy Bulk) products in the Orange Book

Ultravist (pharmacy Bulk) products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection49.9%DiscontinuedNone0None
injectable, injection62.3%Marketed (Rx)None0None
injectable, injection76.9%Marketed (Rx)None0None

NDA 021425, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Questions

Is there a generic for Ultravist (pharmacy Bulk)?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Ultravist (pharmacy Bulk) (iopromide).

What is the generic name for Ultravist (pharmacy Bulk)?

The active ingredient in Ultravist (pharmacy Bulk) is iopromide, 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.

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