FDA Orange Book
Is there a generic for Protopam Chloride?
Protopam Chloride contains pralidoxime 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 Protopam Chloride (pralidoxime chloride).
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Protopam Chloride products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1GM/VIAL | Marketed (Rx) | None | 0 | None |
| injectable, injection | 300MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 500MG | Discontinued | None | 0 | None |
NDA 014134, 018799, 014122, held by BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Protopam Chloride NDC codes
Questions
Is there a generic for Protopam Chloride?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Protopam Chloride (pralidoxime chloride).
What is the generic name for Protopam Chloride?
The active ingredient in Protopam Chloride is pralidoxime 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.