FDA.reportPublic FDA data

Methenamine Mandelate

Product NDC
58657-460
11-digit product format
586570460
Labeler code
58657
Product ID
58657-460_edb58528-7d80-c311-e053-2995a90ac7ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Mandelate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-07-19
Marketing end
2022-12-31
Substance
METHENAMINE MANDELATE
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58657-460DDiscontinued by firm2026-07-31
excluded packagepackage58657-46058657-460-01DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-460-012020-02-11C16284748780-19d75b9d0-baee-f424-e053-dadaa90a57ceMethenamine Mandelate Tablets
58657-460-012020-01-31C16284748780-19d75b9d0-baee-f424-e053-dadaa90a57ceMethenamine Mandelate Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-460-01EA - Each58657-460308a77f4-9dfa-4084-9627-b1712b69cd7a12018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-460-0158657046001100 TABLET, FILM COATED in 1 BOTTLE (58657-460-01) 2018-07-190000-00-00NoNoCurrent