FDA Orange Book
Is there a generic for Provocholine?
Provocholine contains methacholine chloride. 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 Provocholine (methacholine chloride).
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Provocholine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, inhalation | 100MG/VIAL | Marketed (Rx) | None | 0 | None |
| for solution, inhalation | 1600MG/VIAL | Discontinued | None | 0 | None |
NDA 019193, held by METHAPHARM INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Provocholine NDC codes
Questions
Is there a generic for Provocholine?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Provocholine (methacholine chloride).
What is the generic name for Provocholine?
The active ingredient in Provocholine is methacholine chloride, 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.