FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
68071-2357
11-digit product format
680712357
Labeler code
68071
Product ID
68071-2357_4b34f7e8-fb23-1311-e063-6294a90a3a1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenazopyridine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094107

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2357-22025-01-10C16284748780-1f386c64a-0872-0266-e053-dadaa90a7c1aPHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-42025-01-10C16284748780-1f386c64a-0872-0266-e053-dadaa90a7c1aPHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-82025-01-10C16284748780-1f386c64a-0872-0266-e053-dadaa90a7c1aPHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-22023-01-30C16284748780-1f386c64a-0872-0266-e053-dadaa90a7c1aPHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-42023-01-30C16284748780-1f386c64a-0872-0266-e053-dadaa90a7c1aPHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
68071-2357-82023-01-30C16284748780-1f386c64a-0872-0266-e053-dadaa90a7c1aPHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2357-2Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET123
68071-2357-4Phenazopyridine Hydrochloride4 in 1 BOTTLETABLET43
68071-2357-8Phenazopyridine Hydrochloride8 in 1 BOTTLETABLET83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2357PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 3 package rows20250112_bd0ae1dc-f170-eda6-e053-2995a90a6c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSNbd0ae1dc-f170-eda6-e053-2995a90a6c9b3
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDbd0ae1dc-f170-eda6-e053-2995a90a6c9b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2357-26807123570212 TABLET in 1 BOTTLE (68071-2357-2) 12 tablet2021-03-080000-00-00NoNoCurrent
68071-2357-4680712357044 TABLET in 1 BOTTLE (68071-2357-4) 4 tablet2021-03-080000-00-00NoNoCurrent
68071-2357-8680712357088 TABLET in 1 BOTTLE (68071-2357-8) 8 tablet2021-03-080000-00-00NoNoCurrent