FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
65162-520
11-digit product format
651620520
Labeler code
65162
Product ID
65162-520_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
200 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
65162-520-102021-01-29C16284748780-1ba0f9c33-4521-a910-e053-dadaa90a0b85PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-520-10Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-520-10EA - Each65162-520c84f1d21-d3bc-43c2-a22a-c58e90dbfca112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [READYMEDS]5
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
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]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 [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REBEL DISTRIBUTORS CORP]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 [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
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 [REBEL DISTRIBUTORS CORP]2
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [MEDVANTX, 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
65162-520PHENAZOPYRIDINE 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 TabletPSN4f9ddc5b-2cb2-4556-b8ca-32a0283fce798
1094104phenazopyridine HCl 200 MG Oral TabletPSN4f9ddc5b-2cb2-4556-b8ca-32a0283fce798
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD4f9ddc5b-2cb2-4556-b8ca-32a0283fce798
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD4f9ddc5b-2cb2-4556-b8ca-32a0283fce798
1094104phenazopyridine HCl 200 MG Oral TabletPSN32918084-20f5-4050-b94e-09c0dd72e9105
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD32918084-20f5-4050-b94e-09c0dd72e9105
1094107phenazopyridine HCl 100 MG Oral TabletPSN480ee010-26f9-479c-b472-91fed589c6224
1094104phenazopyridine HCl 200 MG Oral TabletPSN480ee010-26f9-479c-b472-91fed589c6224
1094104phenazopyridine HCl 200 MG Oral TabletPSN40e23a87-d8c0-2f03-e054-00144ff88e884
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD480ee010-26f9-479c-b472-91fed589c6224
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD480ee010-26f9-479c-b472-91fed589c6224
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD40e23a87-d8c0-2f03-e054-00144ff88e884
1094104phenazopyridine HCl 200 MG Oral TabletPSNd31ddcfe-08e2-45cc-ae57-2fda7b1edf4b3
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDd31ddcfe-08e2-45cc-ae57-2fda7b1edf4b3
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 TabletPSN3bea4097-a272-4f5e-8f09-13bb24e905ed1
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 TabletPSNa63d3ace-768f-4e1b-a5e9-dad1817453b91
1094104phenazopyridine HCl 200 MG Oral TabletPSN27fdf443-7544-3879-e054-00144ff88e881
1094104phenazopyridine HCl 200 MG Oral TabletPSN0f7c3734-dfa5-7082-e054-00144ff88e881
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD3bea4097-a272-4f5e-8f09-13bb24e905ed1
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 TabletSCDa63d3ace-768f-4e1b-a5e9-dad1817453b91
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD27fdf443-7544-3879-e054-00144ff88e881
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD0f7c3734-dfa5-7082-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65162-520-1065162052010100 in 1 BOTTLEHistorical