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Active ingredient

Methenamine

21 finished FDA listings contain Methenamine as their only active ingredient; 30 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
METHENAMINE, METHENAMINE HIPPURATE, METHENAMINE MANDELATE
Dosage forms
Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
17
Strengths listed
1 g/1 · 1000 mg/1 · 500 mg/1 · 500 mg/5ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6832

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
NDA 016151QUAGEN1967-07-051
NDA 017681ESJAY PHARMA1976-09-091
ANDA 205661AUROBINDO PHARMA LTD2016-07-052
ANDA 212172MICRO LABS2019-08-013
ANDA 210068INGENUS PHARMS LLC2020-11-272
ANDA 217675JUBILANT CADISTA2023-12-011
ANDA 219661ZYDUS LIFESCIENCES2025-03-102

Official labeling on DailyMed

Showing the 12 most recent of 18 labels.

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