FDA Orange Book

Is there a generic for Ruby-fill?

Ruby-fill contains rubidium chloride rb-82. 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 Ruby-fill (rubidium chloride rb-82).

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Ruby-fill products in the Orange Book

Ruby-fill products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, intravenousN/AMarketed (Rx)None0None

NDA 202153, held by JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Ruby-fill NDC codes

Questions

Is there a generic for Ruby-fill?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Ruby-fill (rubidium chloride rb-82).

What is the generic name for Ruby-fill?

The active ingredient in Ruby-fill is rubidium chloride rb-82, 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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