Friday, July 10, 2026

Drug profile · INN

phenazopyridine hydrochloride

phenazopyridine hydrochloride (AZO GANTANOL) is a sodium channel alpha subunit blocker. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — phenazopyridine hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
2
Data quality
0.84

Quick answer

phenazopyridine hydrochloride (AZO GANTANOL) is a sodium channel alpha subunit blocker. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN phenazopyridine hydrochloride
Brand AZO GANTANOL
Mechanism Sodium channel alpha subunit blocker
Target Sodium channel alpha subunit
Route ORAL
Formulation TABLET

Mechanism of action

Sodium channel alpha subunit blocker

Primary target: Sodium channel alpha subunit

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. AM-PHN-004 Phase 3 · Amneal Pharma Europe · Uncomplicated Urinary Tract Infections
  2. Phenazopyridine Hydrochloride Phase 3 · Amneal Pharma Europe · Pain

Related & competitor drugs

  1. carbamazepine Sodium channel alpha subunit blocker
  2. disopyramide phosphate Sodium channel alpha subunit blocker
  3. eslicarbazepine acetate Nervous system (N03)
  4. fosphenytoin sodium Sodium channel alpha subunit blocker
  5. lacosamide Nervous system (N03)
  6. lamotrigine Sodium channel alpha subunit blocker

Frequently asked questions

What is phenazopyridine hydrochloride?

phenazopyridine hydrochloride (AZO GANTANOL) is a sodium channel alpha subunit blocker. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for phenazopyridine hydrochloride?

AZO GANTANOL is a marketed brand name for phenazopyridine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of phenazopyridine hydrochloride?

phenazopyridine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.