FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
67296-1242
Requested package NDC
67296-1242-1
11-digit product format
672961242
Labeler code
67296
Product ID
67296-1242_d61031d4-3dc5-1d54-e053-2995a90acf69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-11-23
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 packagepackage67296-124267296-1242-1IInactivated 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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67296-1242-12026-01-294f4601c8-37f0-4ecc-e054-00144ff88e88
67296-1242-62026-01-294f4601c8-37f0-4ecc-e054-00144ff88e88
67296-1242-12024-07-154f4601c8-37f0-4ecc-e054-00144ff88e88
67296-1242-62024-07-154f4601c8-37f0-4ecc-e054-00144ff88e88
67296-1242-12024-01-304f4601c8-37f0-4ecc-e054-00144ff88e88
67296-1242-62024-01-304f4601c8-37f0-4ecc-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1242-1Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET104
67296-1242-6Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1242PHENAZOPYRIDINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 2 package rows20240716_4f4601c8-37f0-4ecc-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN4f4601c8-37f0-4ecc-e054-00144ff88e884
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD4f4601c8-37f0-4ecc-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1242-16729612420110 TABLET in 1 BOTTLE (67296-1242-1) 10 tablet2015-11-230000-00-00NoNoCurrent