Phenazopyridine Hydrochloride

Product NDC: 50696-003
11-digit product format: 506960003
Labeler code: 50696
Product ID: 50696-003_51a1c6ea-0152-879a-e063-6394a90af1df
Type: HUMAN OTC DRUG
Nonproprietary name: Phenazopyridine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: GPT Pharmaceuticals Private Limited
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2026-04-01
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 99.5 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	GPT Pharmaceuticals Private Limited	7332cbf1-ceda-415b-b4d5-a100057a7d01	2026-05-12	Warnings	Exact identifier ndc (product): 50696-003

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	99.5 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
1094147	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
7332cbf1-ceda-415b-b4d5-a100057a7d01	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50696-003-01	Phenazopyridine Hydrochloride	25000 in 1 DRUM	TABLET	25000		1

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
1094147	phenazopyridine HCl 99.5 MG Oral Tablet	PSN	7332cbf1-ceda-415b-b4d5-a100057a7d01	1
1094147	phenazopyridine hydrochloride 99.5 MG Oral Tablet	SCD	7332cbf1-ceda-415b-b4d5-a100057a7d01	1
1094147	phenazopyridine HCl 99.5 MG Oral Tablet	SY	7332cbf1-ceda-415b-b4d5-a100057a7d01	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50696-003-01	50696000301	25000 TABLET in 1 DRUM (50696-003-01)	25000 tablet	2026-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenazopyridine Hydrochloride - GPT Pharmaceuticals Private Limited	GPT Pharmaceuticals Private Limited	2026-05-12	HUMAN OTC DRUG LABEL	1