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Active ingredient

Procainamide

16 finished FDA listings contain Procainamide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PROCAINAMIDE HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution
Routes
Intramuscular, Intravenous
Manufacturers / labelers
11
Strengths listed
100 mg/ml · 500 mg/ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8700

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 088636INTL MEDICATION1984-07-314
ANDA 089069HOSPIRA1986-02-123
ANDA 206332NEXUS2017-10-132
ANDA 218135GLAND2024-07-225
ANDA 218674CAPLIN2025-02-042

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.