Phenazopyridine Hydrochloride

Product NDC
68788-7981
Requested package NDC
68788-7981-2
11-digit product format
687887981
Labeler code
68788
Product ID
68788-7981_2980ccb0-a69b-426a-9536-19ae22d9ac5b
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
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
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

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 startSampleExclude flagStatus
68788-7981-26878879810220 TABLET in 1 BOTTLE (68788-7981-2) 20 tablet2023-08-23NoNoHistorical