FDA.reportPublic FDA data

PHENAZOPYRIDINE HYDROCHLORIDE

Product NDC
61919-216
Requested package NDC
61919-216-06
11-digit product format
619190216
Labeler code
61919
Product ID
61919-216_d0ec973f-c1a9-6c03-e053-2995a90a60a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DIRECT RX
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-07-19
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 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 packagepackage61919-21661919-216-06IInactivated 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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
61919-216-062025-01-30C16284748780-11030e365-3a1a-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE
61919-216-062024-01-30C16284748780-11030e365-3a1a-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-216-06PHENAZOPYRIDINE HYDROCHLORIDE6 in 1 BOTTLETABLET, COATED67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-216-06EA - Each61919-216836d380f-ab22-449d-bcb7-a2aea66fee4612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-216PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED PHENAZOPYRIDINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]7Legacy NDC, 1 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
61919-216-06619190216066 TABLET, COATED in 1 BOTTLE (61919-216-06) 2017-07-190000-00-00NoNoCurrent