FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
71335-0188
Requested package NDC
71335-0188-9
11-digit product format
713350188
Labeler code
71335
Product ID
71335-0188_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
200 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 packagepackage71335-018871335-0188-9DDiscontinued by firm2026-10-15

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
71335-0188-1EA - Each71335-01887a642db6-8ee1-4990-8276-4978a512af8412018-03-08
71335-0188-2EA - Each71335-0188aea1c29f-76e6-4a1e-bc79-1feea00c30d612018-03-08
71335-0188-3EA - Each71335-018870409ef2-c3f7-4470-ae13-011d68c9a65f12018-03-08
71335-0188-4EA - Each71335-01889d0ff6ba-6865-498e-bd7a-28e7faff755112018-03-08
71335-0188-5EA - Each71335-01887fad6364-088c-41d1-a15b-ad74b5b06f8012018-03-08
71335-0188-6EA - Each71335-01887b1dec6c-ca79-4a1b-827b-7401f9e56c9912018-03-08
71335-0188-7EA - Each71335-018871ed279a-5b04-4d47-b1f6-2ad1010d797c12018-03-08
71335-0188-8EA - Each71335-01880dcb9b6b-8b4b-42c7-a789-487dd5d8e18f12018-03-08
71335-0188-9EA - Each71335-01880e97d33e-4607-422e-9042-0c90d1d099f912018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0188-97133501880918 TABLET, COATED in 1 BOTTLE (71335-0188-9) 2015-11-120000-00-00NoNoCurrent