FDA.reportPublic FDA data

Methenamine Mandelate

Product NDC
62135-200
11-digit product format
621350200
Labeler code
62135
Product ID
62135-200_00225fc8-eb0d-a4cc-e063-6394a90a2acb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Mandelate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-10-01
Substance
METHENAMINE MANDELATE
Active strength
500 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 Mandelate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE MANDELATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii695N30CINR
Rxcui992153, 992184

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
62135-200-01Methenamine Mandelate100 in 1 BOTTLETABLET, FILM COATED1003
62135-200-12Methenamine Mandelate120 in 1 BOTTLETABLET, FILM COATED1203
62135-200-60Methenamine Mandelate60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-200-12EA - Each62135-200c4dcc0a4-6519-4378-8af3-77add24faa0c12021-11-09
62135-200-60EA - Each62135-200d2a24403-2807-4afe-87f1-91dea4c51d5612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-200METHENAMINE MANDELATE TABLET, FILM COATED [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 3 package rows20230711_69efa19c-64a2-41cb-a298-6e9113e57fd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992153methenamine mandelate 1000 MG Oral TabletPSN69efa19c-64a2-41cb-a298-6e9113e57fd73
992184methenamine mandelate 500 MG Oral TabletPSN69efa19c-64a2-41cb-a298-6e9113e57fd73
992153methenamine mandelate 1000 MG Oral TabletSCD69efa19c-64a2-41cb-a298-6e9113e57fd73
992184methenamine mandelate 500 MG Oral TabletSCD69efa19c-64a2-41cb-a298-6e9113e57fd73
992153methenamine mandelate 1 GM Oral TabletSY69efa19c-64a2-41cb-a298-6e9113e57fd73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-200-0162135020001100 TABLET, FILM COATED in 1 BOTTLE (62135-200-01) 2021-10-010000-00-00NoNoCurrent
62135-200-1262135020012120 TABLET, FILM COATED in 1 BOTTLE (62135-200-12) 2021-10-010000-00-00NoNoCurrent
62135-200-606213502006060 TABLET, FILM COATED in 1 BOTTLE (62135-200-60) 2021-10-010000-00-00NoNoCurrent