FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-3443
Requested package NDC
70518-3443-3
11-digit product format
705183443
Labeler code
70518
Product ID
70518-3443_5114de16-3cd7-3270-e063-6294a90a1e19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-06-28
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-344370518-3443-3DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…

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
f6829698-b12e-484d-a322-d2f68586e637Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3443-0Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET3011
70518-3443-1Phenazopyridine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET1211
70518-3443-2Phenazopyridine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET1011
70518-3443-3Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET611

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3443PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250215_f6829698-b12e-484d-a322-d2f68586e637.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 HydrochloridePHENAZOPYRIDINEREMEDYREPACK INC.f6829698-b12e-484d-a322-d2f68586e6372026-08-07Adverse reactionsExact identifier
ndc (package): 70518-3443-3
ndc (product): 70518-3443
ndc11 (package): 70518344303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSNf6829698-b12e-484d-a322-d2f68586e63711
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDf6829698-b12e-484d-a322-d2f68586e63711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3443-3705183443036 TABLET in 1 BOTTLE, PLASTIC (70518-3443-3) 6 tablet2023-08-23NoNoCurrent