Phenazopyridine Hydrochloride

Product NDC: 68071-2357
11-digit product format: 680712357
Labeler code: 68071
Product ID: 68071-2357_4b34f7e8-fb23-1311-e063-6294a90a3a1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenazopyridine
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-02-01
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 28 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
2025-01-11 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	68071-2357-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2357-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2357-2	`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	68071-2357-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-2357-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-2357-2	`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	68071-2357-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-2357-8	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-2357-2	`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	68071-2357-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-2357-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-2357-2	`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	68071-2357-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-2357-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-2357-2	`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	68071-2357-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-2357-8	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-2357-2	`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	68071-2357-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-2357-8	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-2357-2	`1332a3947898…`	`d4bfe170f9cd…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phenazopyridine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENAZOPYRIDINE HYDROCHLORIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0EWG668W17	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094107	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bd0ae1dc-f170-eda6-e053-2995a90a6c9b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-2357-2	2025-01-10	PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-4	2025-01-10	PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-8	2025-01-10	PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-2	2023-01-30	PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-4	2023-01-30	PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-8	2023-01-30	PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2357-2	Phenazopyridine Hydrochloride	12 in 1 BOTTLE	TABLET	12	3
68071-2357-4	Phenazopyridine Hydrochloride	4 in 1 BOTTLE	TABLET	4	3
68071-2357-8	Phenazopyridine Hydrochloride	8 in 1 BOTTLE	TABLET	8	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2357	PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 3 package rows	20250112_bd0ae1dc-f170-eda6-e053-2995a90a6c9b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenazopyridine Hydrochloride	PHENAZOPYRIDINE	NuCare Pharmaceuticals,Inc.	bd0ae1dc-f170-eda6-e053-2995a90a6c9b	2026-02-19	Adverse reactions	Exact identifier ndc (product): 68071-2357

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
1094107	phenazopyridine HCl 100 MG Oral Tablet	PSN	bd0ae1dc-f170-eda6-e053-2995a90a6c9b	3
1094107	phenazopyridine hydrochloride 100 MG Oral Tablet	SCD	bd0ae1dc-f170-eda6-e053-2995a90a6c9b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2357-2	68071235702	12 TABLET in 1 BOTTLE (68071-2357-2)	12 tablet	2021-03-08	0000-00-00	No	No	Current
68071-2357-4	68071235704	4 TABLET in 1 BOTTLE (68071-2357-4)	4 tablet	2021-03-08	0000-00-00	No	No	Current
68071-2357-8	68071235708	8 TABLET in 1 BOTTLE (68071-2357-8)	8 tablet	2021-03-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only	NuCare Pharmaceuticals,Inc.	2026-02-19	HUMAN PRESCRIPTION DRUG LABEL	3