Methenamine Hippurate

Product NDC
59746-797
11-digit product format
597460797
Labeler code
59746
Product ID
59746-797_66ecc892-3ddf-4fc3-b58d-ce1d3581ea2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Hippurate
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA217675
Marketing category
ANDA
Marketing start
2023-01-24
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
59746-797-01Methenamine Hippurate100 in 1 BOTTLETABLET1002
59746-797-65Methenamine Hippurate20 in 1 BOTTLETABLET202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-797-01EA - Each59746-797b551affc-cadc-463f-a3a1-e4a6d88a159512024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-797METHENAMINE HIPPURATE TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240515_4263d826-7de2-4011-b8ec-ba1f5222f0e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992150methenamine hippurate 1 GM Oral TabletPSN4263d826-7de2-4011-b8ec-ba1f5222f0e62
992150methenamine hippurate 1000 MG Oral TabletSCD4263d826-7de2-4011-b8ec-ba1f5222f0e62
992150methenamine hippurate 1 GM Oral TabletSY4263d826-7de2-4011-b8ec-ba1f5222f0e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59746-797-0159746079701100 TABLET in 1 BOTTLE (59746-797-01) 100 tablet2023-01-24NoNoHistorical
59746-797-655974607976520 TABLET in 1 BOTTLE (59746-797-65) 20 tablet2023-01-24NoNoHistorical