FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
71335-0258
Requested package NDC
71335-0258-3
11-digit product format
713350258
Labeler code
71335
Product ID
71335-0258_d4ece333-2022-4e46-858b-0d1397bc3890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-02
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage71335-025871335-0258-3DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
71335-0258-1EA - Each71335-02582e9a3499-36db-4af2-99d5-bbec5476d4fe12018-01-12
71335-0258-2EA - Each71335-0258b1248863-f6ec-443e-8aac-edc9c69b3fb812018-01-12
71335-0258-3EA - Each71335-0258259f1a60-81ad-431b-a616-d19e16ece48e12018-01-12
71335-0258-4EA - Each71335-0258f03fef3a-91fb-474c-ab28-41da81346e0f12018-01-12
71335-0258-5EA - Each71335-02587e9685dd-8085-4e43-8cdb-faae541a01e912018-01-12
71335-0258-6EA - Each71335-02588c7f98b8-9d33-430f-bcc8-addec256493112018-01-12
71335-0258-7EA - Each71335-0258102fa92c-ee25-4acb-a433-bc5f900f3e6112018-01-12
71335-0258-8EA - Each71335-0258e552a228-b1bf-4319-9a30-e8d636b8518c12018-01-12
71335-0258-9EA - Each71335-0258f130c4da-a2fc-40cf-8c51-f010e451c06712018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0258-3713350258039 TABLET, COATED in 1 BOTTLE (71335-0258-3) 2011-08-020000-00-00NoNoCurrent