FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-3986
11-digit product format
705183986
Labeler code
70518
Product ID
70518-3986_5088b292-470f-1443-e063-6394a90a6f2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-15
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 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 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
49baf6e5-133a-4e1a-9740-506673d27cafAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3986-0Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET305
70518-3986-1Phenazopyridine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET125
70518-3986-2Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET65
70518-3986-3Phenazopyridine Hydrochloride50 in 1 BOXTABLET505
70518-3986-4Phenazopyridine Hydrochloride1 in 1 POUCHTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3986PHENAZOPYRIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]1Current NDC, 5 package rows20240116_49baf6e5-133a-4e1a-9740-506673d27caf.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.49baf6e5-133a-4e1a-9740-506673d27caf2026-04-28Warnings, Adverse reactionsExact identifier
ndc (product): 70518-3986

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN49baf6e5-133a-4e1a-9740-506673d27caf5
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD49baf6e5-133a-4e1a-9740-506673d27caf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3986-07051839860030 TABLET in 1 BLISTER PACK (70518-3986-0) 30 tablet2024-01-15NoNoCurrent
70518-3986-17051839860112 TABLET in 1 BOTTLE, PLASTIC (70518-3986-1) 12 tablet2025-10-10NoNoCurrent
70518-3986-2705183986026 TABLET in 1 BOTTLE, PLASTIC (70518-3986-2) 6 tablet2026-02-17NoNoCurrent
70518-3986-37051839860350 POUCH in 1 BOX (70518-3986-3) / 1 TABLET in 1 POUCH (70518-3986-4) 50 pouch2026-04-28NoNoCurrent
70518-3986-4705183986041 in 1 POUCHHistorical