FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
75826-115
11-digit product format
758260115
Labeler code
75826
Product ID
75826-115_e0537551-5536-d23c-e053-2995a90af439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Winder Laboratories, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-11-23
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
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094104Internal RxNorm lookup
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
0a190e86-4074-4822-888e-4952281712eaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75826-115-10Phenazopyridine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75826-115-10EA - Each75826-115ac8ad19d-d48d-4748-82ca-c0ab1ec44e4312016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-115PHENAZOPYRIDINE HYDROCHLORIDE TABLET [WINDER LABORATORIES, LLC]6Current NDC, Legacy NDC, 1 package rows20220601_0a190e86-4074-4822-888e-4952281712ea.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 HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEWinder Laboratories, LLC0a190e86-4074-4822-888e-4952281712ea2022-05-31Adverse reactionsExact identifier
ndc (product): 75826-115

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNdccd9459-d294-4b21-a88b-0b4151d0c7798
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDdccd9459-d294-4b21-a88b-0b4151d0c7798
1094107phenazopyridine HCl 100 MG Oral TabletPSN0a190e86-4074-4822-888e-4952281712ea6
1094104phenazopyridine HCl 200 MG Oral TabletPSN0a190e86-4074-4822-888e-4952281712ea6
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD0a190e86-4074-4822-888e-4952281712ea6
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD0a190e86-4074-4822-888e-4952281712ea6
1094104phenazopyridine HCl 200 MG Oral TabletPSN4f4601c8-37f0-4ecc-e054-00144ff88e884
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD4f4601c8-37f0-4ecc-e054-00144ff88e884
1094104phenazopyridine HCl 200 MG Oral TabletPSNb9f64256-05aa-47f0-b21a-86085099a7ce2
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDb9f64256-05aa-47f0-b21a-86085099a7ce2
1094104phenazopyridine HCl 200 MG Oral TabletPSNc3c3ef8a-a2a8-473a-aae5-f892ddb4d1b21
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc3c3ef8a-a2a8-473a-aae5-f892ddb4d1b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75826-115-1075826011510100 TABLET in 1 BOTTLE, PLASTIC (75826-115-10) 100 tablet2015-11-230000-00-00NoNoCurrent