FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
71205-495
11-digit product format
712050495
Labeler code
71205
Product ID
71205-495_ef143cc7-36f4-430e-9ca2-9a78ee794f88
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71205-495DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-09DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-10DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-12DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-18DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-20DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-24DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-30DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-60DDiscontinued by firm2026-10-12
excluded packagepackage71205-49571205-495-90DDiscontinued by firm2026-10-12

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-495-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-495-09f5e01cc5f278…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
71205-495-09EA - Each71205-495f6a4e2cc-fb9f-4f34-b780-cad8794e100212021-10-08
71205-495-18EA - Each71205-4958da08a64-9e77-44e9-b2f0-b98e76467a6312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-495PHENAZOPYRIDINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]4Legacy NDC20220421_52abda75-4021-41de-94a0-28ddd58ccce6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-495-09712050495099 TABLET, FILM COATED in 1 BOTTLE (71205-495-09) 2021-07-060000-00-00NoNoCurrent
71205-495-107120504951010 TABLET, FILM COATED in 1 BOTTLE (71205-495-10) 2020-10-200000-00-00NoNoCurrent
71205-495-127120504951212 TABLET, FILM COATED in 1 BOTTLE (71205-495-12) 2020-10-200000-00-00NoNoCurrent
71205-495-187120504951818 TABLET, FILM COATED in 1 BOTTLE (71205-495-18) 2021-03-230000-00-00NoNoCurrent
71205-495-207120504952020 TABLET, FILM COATED in 1 BOTTLE (71205-495-20) 2020-10-200000-00-00NoNoCurrent
71205-495-247120504952424 TABLET, FILM COATED in 1 BOTTLE (71205-495-24) 2020-10-200000-00-00NoNoCurrent
71205-495-307120504953030 TABLET, FILM COATED in 1 BOTTLE (71205-495-30) 2020-10-200000-00-00NoNoCurrent
71205-495-607120504956060 TABLET, FILM COATED in 1 BOTTLE (71205-495-60) 2020-10-200000-00-00NoNoCurrent
71205-495-907120504959090 TABLET, FILM COATED in 1 BOTTLE (71205-495-90) 2020-10-200000-00-00NoNoCurrent