Phenazopyridine Hydrochloride

Product NDC: 69367-162
11-digit product format: 693670162
Labeler code: 69367
Product ID: 69367-162_4352ec4b-ccce-40f4-a962-4833550ef7db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenazopyridine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69367-162		D	Discontinued by firm		2026-10-05
excluded package	package	69367-162	69367-162-04	D	Discontinued by firm		2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69367-162-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69367-162-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69367-162-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69367-162-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69367-162-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69367-162-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69367-162-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69367-162-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69367-162-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69367-162-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69367-162-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69367-162-04	`557ba5c1ecfa…`	`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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-162-04	EA - Each	69367-162	9282b5af-9570-46d3-b555-72709a7e91fd	1	2016-12-07

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0EWG668W17	PHENAZOPYRIDINE HYDROCHLORIDE	136-40-3	PHENAZOPYRIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094107	phenazopyridine HCl 100 MG Oral Tablet	PSN	5c52537d-2776-4fc0-80fe-07ea00df6081	9
1094104	phenazopyridine HCl 200 MG Oral Tablet	PSN	5c52537d-2776-4fc0-80fe-07ea00df6081	9
1094107	phenazopyridine hydrochloride 100 MG Oral Tablet	SCD	5c52537d-2776-4fc0-80fe-07ea00df6081	9
1094104	phenazopyridine hydrochloride 200 MG Oral Tablet	SCD	5c52537d-2776-4fc0-80fe-07ea00df6081	9
1094107	phenazopyridine HCl 100 MG Oral Tablet	PSN	93ca3c07-3e69-3a02-e053-2995a90a0811	2
1094107	phenazopyridine hydrochloride 100 MG Oral Tablet	SCD	93ca3c07-3e69-3a02-e053-2995a90a0811	2
1094107	phenazopyridine HCl 100 MG Oral Tablet	PSN	aca04984-d48d-495f-e053-2a95a90aad23	1
1094107	phenazopyridine hydrochloride 100 MG Oral Tablet	SCD	aca04984-d48d-495f-e053-2a95a90aad23	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69367-162-04	69367016204	100 TABLET, FILM COATED in 1 BOTTLE (69367-162-04)	2016-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP	REMEDYREPACK INC.	2024-02-27	HUMAN PRESCRIPTION DRUG LABEL	8
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP	Bryant Ranch Prepack	2023-11-28	HUMAN PRESCRIPTION DRUG LABEL	9
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP	Northwind Pharmaceuticals, LLC	2023-10-26	HUMAN PRESCRIPTION DRUG LABEL	3
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx only	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx only	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	3
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx only	NuCare Pharmaceuticals,Inc.	2022-02-07	HUMAN PRESCRIPTION DRUG LABEL	2
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx only	NuCare Pharmaceuticals,Inc.	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
PHENAZOPYRIDINE HYDROCHLORIDE	Direct_Rx	2021-06-01	HUMAN PRESCRIPTION DRUG LABEL	2
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx only	NuCare Pharmaceuticals,Inc.	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	2
Phenazopyridine Hydrochloride, USP	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	3
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx only	Preferred Pharmaceuticals, Inc.	2020-06-01	HUMAN PRESCRIPTION DRUG LABEL	1
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx only	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-05-26	HUMAN PRESCRIPTION DRUG LABEL	1
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP	Westminster Pharmaceuticals, LLC	2018-12-18	HUMAN PRESCRIPTION DRUG LABEL	8