Home NDC 13925-107 Methenamine Mandelate
Product NDC 13925-107
11-digit product format 139250107
Labeler code 13925
Product ID 13925-107_d8dcc152-9596-4eaf-b4cb-cd4f7d62151e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methenamine Mandelate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Seton Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2010-02-01
Marketing end 0000-00-00
Substance METHENAMINE MANDELATE
Active strength 1000 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 34 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 13925-107-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 13925-107-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 13925-107-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 13925-107-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 13925-107-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 13925-107-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 13925-107-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 13925-107-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 13925-107-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 13925-107-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 13925-107-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 13925-107-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 13925-107-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 13925-107-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 13925-107-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 13925-107-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 13925-107-01 I Inactivated by FDA bd6a592717d7…303034d00443…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHENAMINE MANDELATE ACTIVE INGREDIENT 695N30CINR METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 METHENAMINE ACTIVE MOIETY J50OIX95QV METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13925-107 METHENAMINE MANDELATE TABLET, FILM COATED [SETON PHARMACEUTICALS] 4 Legacy NDC 20220523_d21a1fdb-7111-4038-975f-f93de44d63a7.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 13925-107-01 13925010701 100 TABLET, FILM COATED in 1 BOTTLE (13925-107-01) 2010-02-01 0000-00-00 No No Current