FDA.reportPublic FDA data

Methenamine Mandelate

Product NDC
69367-437
11-digit product format
693670437
Labeler code
69367
Product ID
69367-437_6e6f983d-9926-4c26-afc1-0946184911d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Mandelate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-03-19
Substance
METHENAMINE MANDELATE
Active strength
1000 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methenamine Mandelate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE MANDELATE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
695N30CINRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992153Internal RxNorm lookup
992184Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d76d132-6fd8-4139-989b-0bc38257ea3bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-437-01Methenamine Mandelate100 in 1 BOTTLETABLET, FILM COATED1001
69367-437-60Methenamine Mandelate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-437-01EA - Each69367-437e5103a00-287f-4396-aa93-ef816f37172812026-05-22
69367-437-60EA - Each69367-43770aec5c2-10d3-4724-b206-3593c1699c4912026-05-22

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methenamine MandelateMETHENAMINE MANDELATEWestminster Pharmaceuticals, LLC1d76d132-6fd8-4139-989b-0bc38257ea3b2026-03-26Warnings, Adverse reactionsExact identifier
ndc (product): 69367-437

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992153methenamine mandelate 1000 MG Oral TabletPSNc765a541-7c85-4779-b934-8af738ac49e4100
992153methenamine mandelate 1000 MG Oral TabletSCDc765a541-7c85-4779-b934-8af738ac49e4100
992153methenamine mandelate 1 GM Oral TabletSYc765a541-7c85-4779-b934-8af738ac49e4100
992153methenamine mandelate 1000 MG Oral TabletPSN1d76d132-6fd8-4139-989b-0bc38257ea3b1
992184methenamine mandelate 500 MG Oral TabletPSN1d76d132-6fd8-4139-989b-0bc38257ea3b1
992153methenamine mandelate 1000 MG Oral TabletSCD1d76d132-6fd8-4139-989b-0bc38257ea3b1
992184methenamine mandelate 500 MG Oral TabletSCD1d76d132-6fd8-4139-989b-0bc38257ea3b1
992153methenamine mandelate 1 GM Oral TabletSY1d76d132-6fd8-4139-989b-0bc38257ea3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-437-0169367043701100 TABLET, FILM COATED in 1 BOTTLE (69367-437-01) 2026-03-19NoNoCurrent
69367-437-606936704376060 TABLET, FILM COATED in 1 BOTTLE (69367-437-60) 2026-03-19NoNoCurrent