FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
51293-612
11-digit product format
512930612
Labeler code
51293
Product ID
51293-612_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
200 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct51293-612IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51293-61251293-612-01IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-22PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
2023-01-30PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
2020-02-03PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
2019-11-27PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
51293-612PHENAZOPYRIDINE 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
1094104phenazopyridine HCl 200 MG Oral TabletPSN0027d6f9-4490-4c72-a006-dcbe5bd98990104
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD0027d6f9-4490-4c72-a006-dcbe5bd98990104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51293-612-0151293061201100 TABLET in 1 BOTTLE (51293-612-01) 100 tablet2011-08-230000-00-00NoNoCurrent