FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-3975
11-digit product format
705183975
Labeler code
70518
Product ID
70518-3975_521805ce-3630-8dc7-e063-6294a90ad5e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-06
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-397570518-3975-1DDiscontinued by firm2026-08-17

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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-397570518-3975-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-397570518-3975-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
6eb59b69-4ad0-47b1-bd3c-1d04d0852ec5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3975-0Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3975-1Phenazopyridine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET217
70518-3975-2Phenazopyridine Hydrochloride9 in 1 BOTTLE, PLASTICTABLET97
70518-3975-3Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET67
70518-3975-4Phenazopyridine Hydrochloride50 in 1 BOXTABLET507
70518-3975-5Phenazopyridine Hydrochloride1 in 1 POUCHTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3975PHENAZOPYRIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 6 package rows20240123_6eb59b69-4ad0-47b1-bd3c-1d04d0852ec5.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 HYDROCHLORIDEREMEDYREPACK INC.6eb59b69-4ad0-47b1-bd3c-1d04d0852ec52026-07-27Warnings, Adverse reactionsExact identifier
ndc (product): 70518-3975

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN6eb59b69-4ad0-47b1-bd3c-1d04d0852ec57
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD6eb59b69-4ad0-47b1-bd3c-1d04d0852ec57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3975-07051839750030 TABLET in 1 BLISTER PACK (70518-3975-0) 30 tablet2024-01-06NoNoCurrent
70518-3975-17051839750121 in 1 BOTTLE, PLASTICHistorical
70518-3975-2705183975029 TABLET in 1 BOTTLE, PLASTIC (70518-3975-2) 9 tablet2025-11-01NoNoCurrent
70518-3975-3705183975036 TABLET in 1 BOTTLE, PLASTIC (70518-3975-3) 6 tablet2026-05-13NoNoCurrent
70518-3975-47051839750450 POUCH in 1 BOX (70518-3975-4) / 1 TABLET in 1 POUCH (70518-3975-5) 50 pouch2026-05-14NoNoCurrent
70518-3975-5705183975051 in 1 POUCHHistorical
70518-3975-670518397506100 POUCH in 1 BOX (70518-3975-6) / 1 TABLET in 1 POUCH (70518-3975-5)100 pouch2026-07-260Current