FDA Orange Book

Is there a generic for Multihance Multipack?

Multihance Multipack contains gadobenate dimeglumine. 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 Multihance Multipack (gadobenate dimeglumine).

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Multihance Multipack products in the Orange Book

Multihance Multipack products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, intravenous26.45GM/50ML (529MG/ML)Marketed (Rx)None0None
injectable, intravenous52.9GM/100ML (529MG/ML)Marketed (Rx)None0None

NDA 021358, held by BRACCO DIAGNOSTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Multihance Multipack NDC codes

Questions

Is there a generic for Multihance Multipack?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Multihance Multipack (gadobenate dimeglumine).

What is the generic name for Multihance Multipack?

The active ingredient in Multihance Multipack is gadobenate dimeglumine, 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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