FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-3868
11-digit product format
705183868
Labeler code
70518
Product ID
70518-3868_43dee455-3f27-27eb-e063-6294a90a7ce4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-09-21
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-386870518-3868-0DDiscontinued by firm2026-08-17
excluded packagepackage70518-386870518-3868-2DDiscontinued 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 · 7 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-3868-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-3868-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-3868-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-3868-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-3868-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-3868-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-3868-0cdf11ea48f46…ba0047e9e063…

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
82dc87bb-ba27-4b86-9bc9-18492975ac9fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3868-0Phenazopyridine Hydrochloride9 in 1 BOTTLE, PLASTICTABLET99
70518-3868-1Phenazopyridine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET219
70518-3868-2Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET69
70518-3868-3Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3868PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REMEDYREPACK INC.]7Current NDC, 4 package rows20250309_82dc87bb-ba27-4b86-9bc9-18492975ac9f.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.82dc87bb-ba27-4b86-9bc9-18492975ac9f2026-06-10Adverse reactionsExact identifier
ndc (product): 70518-3868

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN82dc87bb-ba27-4b86-9bc9-18492975ac9f9
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD82dc87bb-ba27-4b86-9bc9-18492975ac9f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3868-0705183868009 in 1 BOTTLE, PLASTICHistorical
70518-3868-17051838680121 TABLET in 1 BOTTLE, PLASTIC (70518-3868-1) 21 tablet2024-09-15NoNoCurrent
70518-3868-2705183868026 in 1 BOTTLE, PLASTICHistorical
70518-3868-37051838680330 TABLET in 1 BLISTER PACK (70518-3868-3) 30 tablet2025-03-07NoNoCurrent