DrugDashboards

Methenamine Mandelate

Methenamine Mandelate · METHENAMINE MANDELATE 500 mg/1 · Tablet, Film Coated · Oral · Chartwell RX, LLC

NDC 62135-0200-01 · 100 TABLET, FILM COATED in 1 BOTTLE · UNAPPROVED DRUG OTHER · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Chartwell Pharmaceuticals Congers, LLC., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for methenamine mandelate (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Methenamine Mandelate (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackMETHENAMINE MANDELATE 1000 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackMETHENAMINE MANDELATE 500 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCMETHENAMINE MANDELATE 1000 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCMETHENAMINE MANDELATE 500 mg/1Jul 15, 2026Sep 2, 2026
Westminster Pharmaceuticals, LLCMETHENAMINE MANDELATE 1000 mg/1Jul 15, 2026Sep 2, 2026
Westminster Pharmaceuticals, LLCMETHENAMINE MANDELATE 500 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Methenamine Mandelate — NDC 62135-0200-01," retrieved September 3, 2026, https://drugdashboards.com/drug/62135020001.

Free to cite with attribution — see how the data is put together.