FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
51655-424
11-digit product format
516550424
Labeler code
51655
Product ID
51655-424_48ff21cd-c20e-07ba-e063-6394a90aa36a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-09-22
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
f2f3e29f-9553-f7c3-e053-2995a90aff36Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-424-27Phenazopyridine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET122
51655-424-53Phenazopyridine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET102
51655-424-87Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-424PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 3 package rows20230328_f2f3e29f-9553-f7c3-e053-2995a90aff36.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 HydrochloridePHENAZOPYRIDINENorthwind Health Company, LLCf2f3e29f-9553-f7c3-e053-2995a90aff362026-01-01Adverse reactionsExact identifier
ndc (product): 51655-424

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNf2f3e29f-9553-f7c3-e053-2995a90aff362
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDf2f3e29f-9553-f7c3-e053-2995a90aff362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-424-275165504242712 TABLET in 1 BOTTLE, PLASTIC (51655-424-27) 12 tablet2022-12-19NoNoCurrent
51655-424-535165504245310 TABLET in 1 BOTTLE, PLASTIC (51655-424-53) 10 tablet2022-09-22NoNoCurrent
51655-424-87516550424876 TABLET in 1 BOTTLE, PLASTIC (51655-424-87) 6 tablet2022-09-22NoNoCurrent