FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
71335-0898
Requested package NDC
71335-0898-8
11-digit product format
713350898
Labeler code
71335
Product ID
71335-0898_f8895d5c-ae2f-426d-ae22-c09bc13c9ef4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-11-10
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 packagepackage71335-089871335-0898-8DDiscontinued by firm2026-10-16

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-089871335-0898-8DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-089871335-0898-8DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0898-1Phenazopyridine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED209
71335-0898-2Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET, FILM COATED129
71335-0898-3Phenazopyridine Hydrochloride9 in 1 BOTTLETABLET, FILM COATED99
71335-0898-4Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED109
71335-0898-5Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED159
71335-0898-6Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1009
71335-0898-7Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET, FILM COATED69
71335-0898-8Phenazopyridine Hydrochloride21 in 1 BOTTLETABLET, FILM COATED219
71335-0898-9Phenazopyridine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0898PHENAZOPYRIDINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]9Legacy NDC, 9 package rows20231129_5c52537d-2776-4fc0-80fe-07ea00df6081.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN5c52537d-2776-4fc0-80fe-07ea00df60819
1094104phenazopyridine HCl 200 MG Oral TabletPSN5c52537d-2776-4fc0-80fe-07ea00df60819
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD5c52537d-2776-4fc0-80fe-07ea00df60819
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD5c52537d-2776-4fc0-80fe-07ea00df60819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0898-87133508980821 TABLET, FILM COATED in 1 BOTTLE (71335-0898-8) 2018-07-110000-00-00NoNoCurrent