Home NDC 42799-105 Methenamine Mandelate
Product NDC 42799-105
11-digit product format 427990105
Labeler code 42799
Product ID 42799-105_03695bb1-8e07-4862-b517-04c39d9abee1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methenamine Mandelate
Dosage form TABLET
Route ORAL
Labeler Edenbridge Pharmaceuticals LLC.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2009-12-15
Substance METHENAMINE MANDELATE
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Additional Listing Data#
Finished product Yes
Brand name base Methenamine Mandelate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHENAMINE MANDELATE 500 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 42799-105-01 Methenamine Mandelate 100 in 1 BOTTLE TABLET 100 8 42799-105-99 Methenamine Mandelate 1 in 1 POUCH TABLET 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHENAMINE MANDELATE ACTIVE INGREDIENT 695N30CINR METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 METHENAMINE ACTIVE MOIETY J50OIX95QV METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42799-105 METHENAMINE MANDELATE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] 5 Current NDC, Legacy NDC, 2 package rows 20211212_cc299e8a-cf9a-4dc6-b6e6-972141e59296.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 Units Marketing start Marketing end Sample Exclude flag Status 42799-105-01 42799010501 100 TABLET in 1 BOTTLE (42799-105-01) 100 tablet 2009-12-15 0000-00-00 No No Current 42799-105-99 42799010599 1 TABLET in 1 POUCH (42799-105-99) 1 tablet 2009-12-15 0000-00-00 No No Current