FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
51293-611
11-digit product format
512930611
Labeler code
51293
Product ID
51293-611_024d385e-7f9c-4805-b659-0b5d7ab58716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
ECI Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-23
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51293-611-012023-03-22C16284748780-19855e2a2-4d28-60a7-e053-dbdaa90a05bd65346b3f-7a71-4b35-84c8-385ded952867
51293-611-012023-01-30C16284748780-19855e2a2-4d28-60a7-e053-dbdaa90a05bd65346b3f-7a71-4b35-84c8-385ded952867

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [CARILION MATERIALS MANAGEMENT]2
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51293-611PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]4Legacy NDC20230323_65346b3f-7a71-4b35-84c8-385ded952867.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN5cb06cfe-9d4e-4900-9989-6445ea55542e101
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD5cb06cfe-9d4e-4900-9989-6445ea55542e101
1094107phenazopyridine HCl 100 MG Oral TabletPSN43c1b32c-23dc-45c7-afc1-b61599eb72582
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD43c1b32c-23dc-45c7-afc1-b61599eb72582
1094107phenazopyridine HCl 100 MG Oral TabletPSN1d514001-291f-a2f4-e063-6394a90aa9051
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD1d514001-291f-a2f4-e063-6394a90aa9051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51293-611-0151293061101100 TABLET in 1 BOTTLE (51293-611-01) 100 tablet2011-08-230000-00-00NoNoCurrent