FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
65162-517
11-digit product format
651620517
Labeler code
65162
Product ID
65162-517_65fb46f1-dc9b-4688-91af-76240f1eee13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-517-102021-01-29C16284748780-1ba0f9c33-4521-a910-e053-dadaa90a0b85PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-517-10Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-517-10EA - Each65162-517f216cf51-9133-4b38-9f22-85932144265512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS]3
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [LIBERTY PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-517PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS LLC]8Legacy NDC, 1 package rows20190517_4f9ddc5b-2cb2-4556-b8ca-32a0283fce79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN849fa5d5-fc5e-4225-a4fc-e8346ef893698
1094107phenazopyridine HCl 100 MG Oral TabletPSN4f9ddc5b-2cb2-4556-b8ca-32a0283fce798
1094104phenazopyridine HCl 200 MG Oral TabletPSN4f9ddc5b-2cb2-4556-b8ca-32a0283fce798
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD849fa5d5-fc5e-4225-a4fc-e8346ef893698
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD4f9ddc5b-2cb2-4556-b8ca-32a0283fce798
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD4f9ddc5b-2cb2-4556-b8ca-32a0283fce798
1094107phenazopyridine HCl 100 MG Oral TabletPSN480ee010-26f9-479c-b472-91fed589c6224
1094104phenazopyridine HCl 200 MG Oral TabletPSN480ee010-26f9-479c-b472-91fed589c6224
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD480ee010-26f9-479c-b472-91fed589c6224
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD480ee010-26f9-479c-b472-91fed589c6224
1094107phenazopyridine HCl 100 MG Oral TabletPSNd64a0f0e-1fa4-47cb-a59e-d294e001ba532
1094104phenazopyridine HCl 200 MG Oral TabletPSNd64a0f0e-1fa4-47cb-a59e-d294e001ba532
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDd64a0f0e-1fa4-47cb-a59e-d294e001ba532
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDd64a0f0e-1fa4-47cb-a59e-d294e001ba532
1094107phenazopyridine HCl 100 MG Oral TabletPSN410bb1b0-e22f-463b-e054-00144ff8d46c1
1094107phenazopyridine HCl 100 MG Oral TabletPSN3bea4097-a272-4f5e-8f09-13bb24e905ed1
1094107phenazopyridine HCl 100 MG Oral TabletPSN91202708-1a78-4c87-9d28-1f8f4a77e9911
1094107phenazopyridine HCl 100 MG Oral TabletPSN0f7c3734-dfa5-7082-e054-00144ff88e881
1094104phenazopyridine HCl 200 MG Oral TabletPSN3bea4097-a272-4f5e-8f09-13bb24e905ed1
1094104phenazopyridine HCl 200 MG Oral TabletPSN0f7c3734-dfa5-7082-e054-00144ff88e881
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD410bb1b0-e22f-463b-e054-00144ff8d46c1
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD3bea4097-a272-4f5e-8f09-13bb24e905ed1
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD91202708-1a78-4c87-9d28-1f8f4a77e9911
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD0f7c3734-dfa5-7082-e054-00144ff88e881
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD3bea4097-a272-4f5e-8f09-13bb24e905ed1
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD0f7c3734-dfa5-7082-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65162-517-1065162051710100 in 1 BOTTLEHistorical