FDA.reportPublic FDA data

Phenazopyridine HCl

Product NDC
10544-055
11-digit product format
105440055
Labeler code
10544
Product ID
10544-055_112f6f15-abfa-07a7-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-14
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-055-102020-01-31C16284748780-19d75b9d0-b31a-f424-e053-dadaa90a57cePhenazopyridine HCl Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-055-10Phenazopyridine HCl10 in 1 BOTTLETABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-055-10EA - Each10544-055d2cae59d-4a77-4faa-9462-03d7f4fddfe512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-055PHENAZOPYRIDINE HCL TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150313_112eb023-00b2-5a8c-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN112eb023-00b2-5a8c-e054-00144ff88e882
1094104phenazopyridine HCl 200 MG Oral TabletPSN112eb023-00b2-5a8c-e054-00144ff88e882
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD112eb023-00b2-5a8c-e054-00144ff88e882
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD112eb023-00b2-5a8c-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-055-101054400551010 in 1 BOTTLEHistorical