FDA Orange Book
Is there a generic for Cyanokit?
Cyanokit contains hydroxocobalamin. 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 Cyanokit (hydroxocobalamin).
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Cyanokit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2.5GM/VIAL (5GM/KIT) | Discontinued | None | 0 | None |
| injectable, injection | 5GM/VIAL (5GM/KIT) | Marketed (Rx) | None | 0 | None |
NDA 022041, held by BTG INTERNATIONAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cyanokit NDC codes
Questions
Is there a generic for Cyanokit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cyanokit (hydroxocobalamin).
What is the generic name for Cyanokit?
The active ingredient in Cyanokit is hydroxocobalamin, 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.