Home NDC 62135-201 Methenamine Mandelate
Product NDC 62135-201
11-digit product format 621350201
Labeler code 62135
Product ID 62135-201_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 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 Mandelate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHENAMINE MANDELATE 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 695N30CINR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992153 Internal RxNorm lookup 992184 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-201-01 Methenamine Mandelate 100 in 1 BOTTLE TABLET, FILM COATED 100 3 62135-201-12 Methenamine Mandelate 120 in 1 BOTTLE TABLET, FILM COATED 120 3 62135-201-60 Methenamine Mandelate 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-201 METHENAMINE MANDELATE TABLET, FILM COATED [CHARTWELL RX, LLC] 3 Current NDC, Legacy NDC, 3 package rows 20230711_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 62135-201-01 62135020101 100 TABLET, FILM COATED in 1 BOTTLE (62135-201-01) 2021-10-01 0000-00-00 No No Current 62135-201-12 62135020112 120 TABLET, FILM COATED in 1 BOTTLE (62135-201-12) 2021-10-01 0000-00-00 No No Current 62135-201-60 62135020160 60 TABLET, FILM COATED in 1 BOTTLE (62135-201-60) 2021-10-01 0000-00-00 No No Current