PHENAZOPYRIDINE HYDROCHLORIDE

Product NDC: 64950-551
Requested package NDC: 64950-551-01
11-digit product format: 649500551
Labeler code: 64950
Product ID: 64950-551_af00a22c-46a2-4a41-b37e-cffebedead20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Genus Lifesciences Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2026-06-08
Substance: PHENAZOPYRIDINE HYDROCHLORIDE
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	200 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094104	Internal RxNorm lookup
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
991b3b97-9cea-4c48-90a4-ebff55417d98	Available on FDA.report

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	Genus Lifesciences Inc.	991b3b97-9cea-4c48-90a4-ebff55417d98	2026-07-14	Adverse reactions	Exact identifier ndc (package): 64950-551-01 ndc (product): 64950-551 ndc11 (package): 64950055101

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64950-551-01	64950055101	100 TABLET in 1 BOTTLE (64950-551-01)	100 tablet	2026-06-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenazopyridine Hydrochloride Tablets, USP	Genus Lifesciences Inc.	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	2