FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
68788-7981
11-digit product format
687887981
Labeler code
68788
Product ID
68788-7981_b0cdcdcc-66b2-4a5e-99eb-f63f8ff20103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-07-28
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
132cc592-6b03-4b75-bf39-df476fb9dc81Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7981-1Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET156
68788-7981-6Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7981-1EA - Each68788-7981198483a4-0217-460e-8a51-f8ab1e9a9f7b12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7981PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20240731_132cc592-6b03-4b75-bf39-df476fb9dc81.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINEPreferred Pharmaceuticals Inc.132cc592-6b03-4b75-bf39-df476fb9dc812026-08-14Adverse reactionsExact identifier
ndc (product): 68788-7981

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN132cc592-6b03-4b75-bf39-df476fb9dc816
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD132cc592-6b03-4b75-bf39-df476fb9dc816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7981-16878879810115 TABLET in 1 BOTTLE (68788-7981-1) 15 tablet2021-07-280000-00-00NoNoCurrent
68788-7981-6687887981066 TABLET in 1 BOTTLE (68788-7981-6) 6 tablet2023-08-25NoNoCurrent