FDA.reportPublic FDA data

Methenamine Mandelate

Product NDC
85477-115
11-digit product format
854770115
Labeler code
85477
Product ID
85477-115_4fa726e6-84de-0f28-e063-6294a90aafe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Mandelate
Dosage form
SOLUTION
Route
ORAL
Labeler
Oncora Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-04-20
Substance
METHENAMINE MANDELATE
Active strength
500 mg/5mL
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 MANDELATE500 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii695N30CINR
Rxcui2741045

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
85477-115-16Methenamine Mandelate473 mL in 1 BOTTLESOLUTION4731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741045methenamine mandelate 500 MG in 5 mL Oral SolutionPSNd4b79e41-eb29-4d30-aa8f-e964c16bf0021
2741045methenamine mandelate 100 MG/ML Oral SolutionSCDd4b79e41-eb29-4d30-aa8f-e964c16bf0021
2741045methenamine mandelate 500 MG per 5 ML Oral SolutionSYd4b79e41-eb29-4d30-aa8f-e964c16bf0021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-115-1685477011516473 mL in 1 BOTTLE (85477-115-16) 473 ml2026-04-20NoNoCurrent