FDA.reportPublic FDA data

PHENAZOPYRIDINE HYDROCHLORIDE

Product NDC
62135-403
11-digit product format
621350403
Labeler code
62135
Product ID
62135-403_45ae56cd-d6c6-3ad2-e063-6394a90a8ebf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-23
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
2026-12-31

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 · 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
9ed3cf8c-e1c1-4290-b094-25ac6f7a9a56Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-403-60PHENAZOPYRIDINE HYDROCHLORIDE60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-403PHENAZOPYRIDINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]2Current NDC, Legacy NDC, 1 package rows20241025_9ed3cf8c-e1c1-4290-b094-25ac6f7a9a56.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 HYDROCHLORIDEChartwell RX, LLC9ed3cf8c-e1c1-4290-b094-25ac6f7a9a562025-12-11Adverse reactionsExact identifier
ndc (product): 62135-403

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN9ed3cf8c-e1c1-4290-b094-25ac6f7a9a563
1094104phenazopyridine HCl 200 MG Oral TabletPSN9ed3cf8c-e1c1-4290-b094-25ac6f7a9a563
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD9ed3cf8c-e1c1-4290-b094-25ac6f7a9a563
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD9ed3cf8c-e1c1-4290-b094-25ac6f7a9a563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-403-606213504036060 TABLET in 1 BOTTLE (62135-403-60) 60 tablet2022-09-010000-00-00NoNoCurrent