Phenazopyridine Hydrochloride

Product NDC: 51293-811
11-digit product format: 512930811
Labeler code: 51293
Product ID: 51293-811_1c1118af-aafb-40a7-9967-13751b416918
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenazopyridine
Dosage form: TABLET
Route: ORAL
Labeler: ECI Pharmaceuticals, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-02-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51293-811		D	Discontinued by firm		2026-08-17
excluded package	package	51293-811	51293-811-01	D	Discontinued by firm		2026-08-17

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 · 36 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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`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	51293-811-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51293-811-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51293-811-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51293-811-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51293-811-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51293-811-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51293-811-01	`bd6a592717d7…`	`303034d00443…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51293-811-01	2026-01-22	C162847	48780-1	d6a99b39-9b39-a426-e053-dadaa90af4c2	PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
51293-811-01	2022-01-28	C162847	48780-1	d6a99b39-9b39-a426-e053-dadaa90af4c2	PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51293-811-01	EA - Each	51293-811	e998c054-f0b4-4403-ac3d-ee046637b32a	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENAZOPYRIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	0EWG668W17	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
PHENAZOPYRIDINE	ACTIVE MOIETY	K2J09EMJ52	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51293-811	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]	6	Legacy NDC	20201228_c2049b62-04d7-44a4-968c-a1e7fccb0125.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0EWG668W17	PHENAZOPYRIDINE HYDROCHLORIDE	136-40-3	PHENAZOPYRIDINE HYDROCHLORIDE
K2J09EMJ52	PHENAZOPYRIDINE	94-78-0	Phenazopyridine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094104	phenazopyridine HCl 200 MG Oral Tablet	PSN	b34bb613-9ae8-1c5f-e053-2995a90aae6a	3
1094104	phenazopyridine hydrochloride 200 MG Oral Tablet	SCD	b34bb613-9ae8-1c5f-e053-2995a90aae6a	3
1094107	phenazopyridine HCl 100 MG Oral Tablet	PSN	b4d22d69-b225-46b8-84a1-52321bb88804	1
1094104	phenazopyridine HCl 200 MG Oral Tablet	PSN	b4d22d69-b225-46b8-84a1-52321bb88804	1
1094107	phenazopyridine hydrochloride 100 MG Oral Tablet	SCD	b4d22d69-b225-46b8-84a1-52321bb88804	1
1094104	phenazopyridine hydrochloride 200 MG Oral Tablet	SCD	b4d22d69-b225-46b8-84a1-52321bb88804	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51293-811-01	51293081101	100 TABLET in 1 BOTTLE (51293-811-01)	100 tablet	2011-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENAZOPYRIDINE HYDROCHLORIDE 200mg TABLETS	RedPharm Drug, Inc. \| RedPharm Drug	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	3
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	Bryant Ranch Prepack	2024-01-17	HUMAN PRESCRIPTION DRUG LABEL	5
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	Lake Erie Medical DBA Quality Care Products LLC	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	3
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	Bryant Ranch Prepack	2020-12-28	HUMAN PRESCRIPTION DRUG LABEL	4
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	Bryant Ranch Prepack	2020-12-28	HUMAN PRESCRIPTION DRUG LABEL	3
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	ECI Pharmaceuticals, LLC	2020-12-27	HUMAN PRESCRIPTION DRUG LABEL	6
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	Bryant Ranch Prepack	2020-12-07	HUMAN PRESCRIPTION DRUG LABEL	7
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	1
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	Aidarex Pharmaceuticals LLC	2017-02-24	HUMAN PRESCRIPTION DRUG LABEL	1