Methenamine Hippurate

Product NDC
72603-816
11-digit product format
726030816
Labeler code
72603
Product ID
72603-816_83850c2e-5867-4acb-bd35-1261adb5b126
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Hippurate
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA205661
Marketing category
ANDA
Marketing start
2025-04-01
Substance
METHENAMINE HIPPURATE
Active strength
1 g/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 Hippurate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE HIPPURATE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM329791L57
Rxcui992150

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
72603-816-01Methenamine Hippurate100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-816-01EA - Each72603-81647aa2a03-2d4c-403d-adfc-5177293f656a12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-816METHENAMINE HIPPURATE TABLET [NORTHSTAR RX LLC]1Current NDC, 1 package rows20250402_3c9e5bea-f61d-48c3-8e05-640eccccf2ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992150methenamine hippurate 1 GM Oral TabletPSN3c9e5bea-f61d-48c3-8e05-640eccccf2ba2
992150methenamine hippurate 1000 MG Oral TabletSCD3c9e5bea-f61d-48c3-8e05-640eccccf2ba2
992150methenamine hippurate 1 GM Oral TabletSY3c9e5bea-f61d-48c3-8e05-640eccccf2ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-816-0172603081601100 TABLET in 1 BOTTLE (72603-816-01) 100 tablet2025-04-01NoNoHistorical