FDA.reportPublic FDA data

Phenazopyridine HCl 100mg

Product NDC
58657-450
Requested package NDC
58657-450-01
11-digit product format
586570450
Labeler code
58657
Product ID
58657-450_ecc4ce26-c4ab-76d1-e053-2995a90a6de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-12-31
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58657-45058657-450-01DDiscontinued by firm2026-10-05

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-450-012020-02-11C16284748780-19d75b9d0-f2bc-f424-e053-dadaa90a57cePhenazopyridine HCl Oral Tablets, USP
58657-450-012020-01-31C16284748780-19d75b9d0-f2bc-f424-e053-dadaa90a57cePhenazopyridine HCl Oral Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-450-01EA - Each58657-450b711dc5e-9a68-41c0-bc50-63ce0ef2797f12014-12-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN53c8b026-121b-4767-8b0d-36d72f8b8f90101
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD53c8b026-121b-4767-8b0d-36d72f8b8f90101
1094107phenazopyridine HCl 100 MG Oral TabletPSN4fd00f25-026b-3ced-e054-00144ff88e882
1094107phenazopyridine HCl 100 MG Oral TabletPSNf6f3c132-442f-4397-88ab-b20fe0c640092
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD4fd00f25-026b-3ced-e054-00144ff88e882
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDf6f3c132-442f-4397-88ab-b20fe0c640092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-450-0158657045001100 TABLET in 1 BOTTLE (58657-450-01) 100 tablet2014-12-310000-00-00NoNoCurrent