FDA.reportPublic FDA data

Methenamine Hippurate

Product NDC
42571-332
11-digit product format
425710332
Labeler code
42571
Product ID
42571-332_350168e0-c68a-6cfa-e063-6294a90ab7fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Hippurate
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA212172
Marketing category
ANDA
Marketing start
2019-08-15
Substance
METHENAMINE HIPPURATE
Active strength
1000 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methenamine Hippurate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE HIPPURATE1000 mg/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
42571-332-01Methenamine Hippurate100 in 1 BOTTLETABLET1004
42571-332-23Methenamine Hippurate80 in 1 CARTONTABLET804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-332-01EA - Each42571-332145f1cbf-f9f3-41d0-bea1-aea4a1c752bc12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-332METHENAMINE HIPPURATE (METHENAMINE HIPPURATE) TABLET [MICRO LABS LIMITED]4Current NDC, Legacy NDC, 2 package rows20250515_e07ddd63-4725-49db-bec2-bd4f966c6e48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992150methenamine hippurate 1 GM Oral TabletPSNe07ddd63-4725-49db-bec2-bd4f966c6e484
992150methenamine hippurate 1000 MG Oral TabletSCDe07ddd63-4725-49db-bec2-bd4f966c6e484
992150methenamine hippurate 1 GM Oral TabletSYe07ddd63-4725-49db-bec2-bd4f966c6e484
992150methenamine hippurate 1 GM Oral TabletPSNb581b655-62a4-2aa9-e053-2a95a90aa8233
992150methenamine hippurate 1000 MG Oral TabletSCDb581b655-62a4-2aa9-e053-2a95a90aa8233
992150methenamine hippurate 1 GM Oral TabletSYb581b655-62a4-2aa9-e053-2a95a90aa8233
992150methenamine hippurate 1 GM Oral TabletPSNfcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be2
992150methenamine hippurate 1000 MG Oral TabletSCDfcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be2
992150methenamine hippurate 1 GM Oral TabletSYfcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-332-0142571033201100 TABLET in 1 BOTTLE (42571-332-01) 100 tablet2019-08-150000-00-00NoNoCurrent
42571-332-234257103322380 TABLET in 1 CARTON (42571-332-23) 80 tablet2019-08-150000-00-00NoNoCurrent