FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
68788-7902
11-digit product format
687887902
Labeler code
68788
Product ID
68788-7902_fc4684d1-34c4-464b-90cd-e89029407116
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-05-14
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 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
1094104Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0e5d32e-075f-4c76-8332-a06560001efeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7902-1Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET155
68788-7902-9Phenazopyridine Hydrochloride9 in 1 BOTTLETABLET95

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7902-1EA - Each68788-790278f90ae1-f8bf-4275-acc2-2ef2d674849712021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7902PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240731_c0e5d32e-075f-4c76-8332-a06560001efe.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.c0e5d32e-075f-4c76-8332-a06560001efe2026-08-14Adverse reactionsExact identifier
ndc (product): 68788-7902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNc0e5d32e-075f-4c76-8332-a06560001efe5
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc0e5d32e-075f-4c76-8332-a06560001efe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7902-16878879020115 TABLET in 1 BOTTLE (68788-7902-1) 15 tablet2021-05-140000-00-00NoNoCurrent
68788-7902-9687887902099 TABLET in 1 BOTTLE (68788-7902-9) 9 tablet2023-08-25NoNoCurrent