Phenazopyridine Hydrochloride

Product NDC: 70518-0218
11-digit product format: 705180218
Labeler code: 70518
Product ID: 70518-0218_4b1ed8b2-57fd-854f-e063-6294a90a9154
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenazopyridine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2017-02-14
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 package	package	70518-0218	70518-0218-1	D	Discontinued by firm		2026-08-17
excluded package	package	70518-0218	70518-0218-2	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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	70518-0218-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70518-0218-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-0218-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-0218-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	70518-0218-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	70518-0218-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	70518-0218-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	70518-0218-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	70518-0218-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	70518-0218-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	70518-0218-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	70518-0218-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	70518-0218-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	70518-0218-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
7e131f69-d259-404d-a859-0497f5cbe856	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-0218-0	Phenazopyridine Hydrochloride	6 in 1 BOTTLE, PLASTIC	TABLET	6	18
70518-0218-1	Phenazopyridine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	18
70518-0218-2	Phenazopyridine Hydrochloride	10 in 1 BOTTLE, PLASTIC	TABLET	10	18
70518-0218-3	Phenazopyridine Hydrochloride	12 in 1 BOTTLE, PLASTIC	TABLET	12	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0218	PHENAZOPYRIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	12	Current NDC, Legacy NDC, 4 package rows	20250425_7e131f69-d259-404d-a859-0497f5cbe856.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 HYDROCHLORIDE	REMEDYREPACK INC.	7e131f69-d259-404d-a859-0497f5cbe856	2026-06-24	Adverse reactions	Exact identifier ndc (product): 70518-0218

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	7e131f69-d259-404d-a859-0497f5cbe856	18
1094107	phenazopyridine hydrochloride 100 MG Oral Tablet	SCD	7e131f69-d259-404d-a859-0497f5cbe856	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-0218-0	70518021800	6 TABLET in 1 BOTTLE, PLASTIC (70518-0218-0)	6 tablet	2017-02-14	No	No	Current
70518-0218-1	70518021801	30 in 1 BLISTER PACK					Historical
70518-0218-2	70518021802	10 in 1 BOTTLE, PLASTIC					Historical
70518-0218-3	70518021803	12 TABLET in 1 BOTTLE, PLASTIC (70518-0218-3)	12 tablet	2026-01-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rev 12/21 Rx Only CAUTION: Federal law prohibits dispensing without prescription	REMEDYREPACK INC.	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	19