FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-3443
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

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 Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094107

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

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 startMarketing endSampleExclude flagStatus
70518-3443-07051834430030 TABLET in 1 BLISTER PACK (70518-3443-0) 30 tablet2022-06-280000-00-00NoNoCurrent
70518-3443-17051834430112 TABLET in 1 BOTTLE, PLASTIC (70518-3443-1) 12 tablet2023-05-25NoNoHistorical
70518-3443-27051834430210 in 1 BOTTLE, PLASTICHistorical
70518-3443-3705183443036 TABLET in 1 BOTTLE, PLASTIC (70518-3443-3) 6 tablet2023-08-23NoNoHistorical