FDA.reportPublic FDA data

PHENAZOPYRIDINE HYDROCHLORIDE

Product NDC
61919-678
Requested package NDC
61919-678-06
11-digit product format
619190678
Labeler code
61919
Product ID
61919-678_d0ec973f-c1a9-6c03-e053-2995a90a60a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-05-01
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage61919-67861919-678-06IInactivated by FDA2026-10-05

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
61919-678-062025-01-30C16284748780-11030e365-3a1a-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE
61919-678-092025-01-30C16284748780-11030e365-3a1a-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE
61919-678-102025-01-30C16284748780-11030e365-3a1a-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-678-06PHENAZOPYRIDINE HYDROCHLORIDE6 in 1 BOTTLETABLET, FILM COATED67
61919-678-09PHENAZOPYRIDINE HYDROCHLORIDE9 in 1 BOTTLETABLET, FILM COATED97
61919-678-10PHENAZOPYRIDINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-678-06EA - Each61919-678601ac94b-2dd3-40d9-97aa-81a79db4774912019-05-02
61919-678-09EA - Each61919-67850125ba5-afc7-4160-9eea-761cdacde74512021-12-08
61919-678-10EA - Each61919-678fa3f7f53-ce47-45c7-a373-2eee663aba7512019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-678PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED PHENAZOPYRIDINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]7Legacy NDC, 3 package rows20211117_549d08f7-da3b-5873-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN549d08f7-da3b-5873-e054-00144ff88e887
1094104phenazopyridine HCl 200 MG Oral TabletPSN549d08f7-da3b-5873-e054-00144ff88e887
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD549d08f7-da3b-5873-e054-00144ff88e887
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD549d08f7-da3b-5873-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-678-06619190678066 TABLET, FILM COATED in 1 BOTTLE (61919-678-06) 2019-05-010000-00-00NoNoCurrent