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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
695N30CINRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992153Internal RxNorm lookup
992184Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
69efa19c-64a2-41cb-a298-6e9113e57fd7Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methenamine MandelateMETHENAMINE MANDELATEChartwell RX, LLC69efa19c-64a2-41cb-a298-6e9113e57fd72023-07-10Warnings, Adverse reactionsExact identifier
ndc (product): 62135-200

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