FDA.reportPublic FDA data

Methenamine Mandelate

Product NDC
42799-105
11-digit product format
427990105
Labeler code
42799
Product ID
42799-105_03695bb1-8e07-4862-b517-04c39d9abee1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Mandelate
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-12-15
Substance
METHENAMINE MANDELATE
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42799-10542799-105-99DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methenamine MandelateMETHENAMINE MANDELATEEdenbridge Pharmaceuticals LLC.cc299e8a-cf9a-4dc6-b6e6-972141e592962026-01-22Adverse reactionsExact identifier
ndc (product): 42799-105

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE MANDELATE500 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
cc299e8a-cf9a-4dc6-b6e6-972141e59296Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-105-01Methenamine Mandelate100 in 1 BOTTLETABLET1008
42799-105-99Methenamine Mandelate1 in 1 POUCHTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-105-01EA - Each42799-1054dbd21f6-9e01-42f4-b585-68a2062ffa2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHENAMINE MANDELATEACTIVE INGREDIENT695N30CINRMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
METHENAMINEACTIVE MOIETYJ50OIX95QVMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-105METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]5Current NDC, Legacy NDC, 2 package rows20211212_cc299e8a-cf9a-4dc6-b6e6-972141e59296.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992153methenamine mandelate 1000 MG Oral TabletPSNcc299e8a-cf9a-4dc6-b6e6-972141e592968
992184methenamine mandelate 500 MG Oral TabletPSNcc299e8a-cf9a-4dc6-b6e6-972141e592968
992153methenamine mandelate 1000 MG Oral TabletSCDcc299e8a-cf9a-4dc6-b6e6-972141e592968
992184methenamine mandelate 500 MG Oral TabletSCDcc299e8a-cf9a-4dc6-b6e6-972141e592968
992153methenamine mandelate 1 GM Oral TabletSYcc299e8a-cf9a-4dc6-b6e6-972141e592968

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-105-0142799010501100 TABLET in 1 BOTTLE (42799-105-01) 100 tablet2009-12-150000-00-00NoNoCurrent
42799-105-99427990105991 TABLET in 1 POUCH (42799-105-99) 1 tablet2009-12-150000-00-00NoNoCurrent