FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
71205-998
Requested package NDC
71205-998-20
11-digit product format
712050998
Labeler code
71205
Product ID
71205-998_a4c41d5c-157d-4350-a4b3-b61f9650372d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
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 packagepackage71205-99871205-998-20DDiscontinued 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 packagepackage71205-99871205-998-20DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-99871205-998-20DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-998-00EA - Each71205-99891927004-4bd8-4da5-9c75-5a0038333f8b12021-06-02
71205-998-10EA - Each71205-998290a8594-32dc-4e46-9c17-72e9bc28b5dd12021-06-02
71205-998-12EA - Each71205-998d9526b50-0565-403b-81ea-782d39a0256a12021-06-02
71205-998-20EA - Each71205-998137e0615-fae9-4231-8600-a4471817c29a12021-06-02
71205-998-24EA - Each71205-99811ff20f1-5327-4f0b-87c9-dfa97251436912021-06-02
71205-998-55EA - Each71205-9982161c7cc-8b68-4bb4-848a-c10eab99eed412021-06-02
71205-998-90EA - Each71205-998af2e3378-d70e-432a-b1f8-6bbbc44ec54212021-06-02
71205-998-96EA - Each71205-99872561001-dc26-4da7-9fa1-28624d44565412021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-998PHENAZOPYRIDINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3Legacy NDC20220412_2819a501-5ff9-4179-af83-e1a7c91636a7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-998-207120509982020 TABLET, FILM COATED in 1 BOTTLE (71205-998-20) 2019-12-190000-00-00NoNoCurrent