FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
67296-1212
Requested package NDC
67296-1212-6
11-digit product format
672961212
Labeler code
67296
Product ID
67296-1212_d61018ec-f0b5-36df-e053-2995a90a0b29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 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 packagepackage67296-121267296-1212-6IInactivated by FDA2026-09-14

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
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
67296-1212-62024-07-15C16284748780-11030e365-35aa-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE 200mg TABLETS
67296-1212-62024-01-30C16284748780-11030e365-35aa-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE 200mg TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1212-6Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1212PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20240716_b34bb613-9ae8-1c5f-e053-2995a90aae6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNb34bb613-9ae8-1c5f-e053-2995a90aae6a3
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDb34bb613-9ae8-1c5f-e053-2995a90aae6a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1212-6672961212066 TABLET in 1 BOTTLE (67296-1212-6) 6 tablet2011-02-010000-00-00NoNoCurrent