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Prescription medicine

Methenamine First approved as Urex

Methenamine (Urex) is a prescription medicine with an FDA approval on record since 1967. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.313 per methenamine hipp 1 g tablet in the October 7, 2026 NADAC survey.

  • Generic listed

Check it at the source: the methenamine FDA label on DailyMed (effective August 7, 2026, ANI Pharmaceuticals, Inc.); the NDA 16151 record on Drugs@FDA; every methenamine label on DailyMed.

Highlights of the record

FDA label of August 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary.

Forms and strengths

  • 1 g
  • 1000 mg

Tablet.

On the market

Earliest approval on file
July 5, 1967 Urex, Quagen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
6 first June 20, 2003; 5 with a marketed status in Drugs@FDA
Labelers listed (NDC)
12 of which 10 under generic applications, 2 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$0.313 per tablet Methenamine hipp 1 g tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
1,210 through July 30, 2026

What is methenamine used for?

From the label: indications and usage

Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets and other antibacterial drugs, methenamine hippurate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. […]

Conditions named in the indications of methenamine's FDA labels, with every medicine labeled for each:

From other methenamine labels

Urinary tract infections: INDICATIONS & USAGE Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary.

Source: FDA drug label (Methenamine Hippurate), ANI Pharmaceuticals, Inc., effective August 7, 2026 (SPL set a3eeacd4-1983-49ec-a60d-3abaf505ce57), via openFDA; the full label on DailyMed

Is there a generic for methenamine (Urex)?

The FDA approved the first generic methenamine on June 20, 2003. 6 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists methenamine from 10 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

  • 1967 earliest approval on file
  • 2003 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for methenamine (Urex)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.313 per Methenamine hipp 1 g tablet, down 15% from $0.367 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Methenamine hipp 1 g tablet (generic)
$0.497
$0.307
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Methenamine hipp 1 g tabletGeneric$0.313 per tablet$9.38-15%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the methenamine label say about other medicines?

The methenamine label names no other medicine on this site. The labels of 6 other medicines name methenamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name methenamine

Check methenamine against other medicines

Source: FDA drug label (Methenamine Hippurate), ANI Pharmaceuticals, Inc., effective August 7, 2026 (SPL set a3eeacd4-1983-49ec-a60d-3abaf505ce57), via openFDA; the full label on DailyMed

What do FAERS reports show for methenamine?

The FDA Adverse Event Reporting System holds 1,210 reports that list methenamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 75 are coded as a death and 335 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Urinary Tract Infection (a use or a product term, not a reaction)163
  • Diarrhoea81
  • Nausea (named in the label)80
  • Drug Ineffective (a use or a product term, not a reaction)75
  • Fall74
  • Fatigue74
  • Headache65
  • Dizziness60

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as methenamine?

9 other medicines are given the same way (oral) and in the same FDA class as methenamine or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
DoxycyclineUrinary tract infections71 labelers$0.118 per tablet 100 mg tabletA presentation being discontinued
Amoxicillin and clavulanateUrinary tract infections31 labelers$0.0693 per mL 600-42.9 mg/5 mL susNo current entry
NitrofurantoinUrinary tract infections47 labelers$0.165 per capsule 50 mg capsuleA presentation being discontinued
MinocyclineUrinary tract infections21 labelers$0.343 per capsule 100 mg capsuleNo current entry
FosfomycinUrinary tract infections10 labelers$26.22 per unit 3 g sachetNo current entry
SulfadiazineUrinary tract infections2 labelers$15.06 per tablet 500 mg tabletNo current entry
GepotidacinUrinary tract infectionsnone listed$91.40 per tablet 750 mg tabletNo current entry
PivmecillinamUrinary tract infectionsnone listedn/aNo current entry

Every medicine labeled for the same conditions as methenamine

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does methenamine compare with medicines for the same use?

2 side-by-side pages set methenamine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to methenamine
9 medicines for the same use
Methenamine side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other