FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
65162-681
11-digit product format
651620681
Labeler code
65162
Product ID
65162-681_9b599d15-523d-4e57-a844-800d995d35e5
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
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenazopyridine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094104Internal RxNorm lookup
1094107Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b424b50f-990b-4018-a815-0311693cabb3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-681-10Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET10013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-681PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 1 package rows20241031_b424b50f-990b-4018-a815-0311693cabb3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINEAmneal Pharmaceuticals LLCb424b50f-990b-4018-a815-0311693cabb32024-10-30Adverse reactionsExact identifier
ndc (product): 65162-681

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN7367afd6-6bf6-4240-a274-79b7a5de9715102
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD7367afd6-6bf6-4240-a274-79b7a5de9715102
1094107phenazopyridine HCl 100 MG Oral TabletPSN1522921b-d6c2-420d-ba0d-39ac16ba8b3716
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD1522921b-d6c2-420d-ba0d-39ac16ba8b3716
1094107phenazopyridine HCl 100 MG Oral TabletPSNb424b50f-990b-4018-a815-0311693cabb313
1094104phenazopyridine HCl 200 MG Oral TabletPSNb424b50f-990b-4018-a815-0311693cabb313
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDb424b50f-990b-4018-a815-0311693cabb313
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDb424b50f-990b-4018-a815-0311693cabb313
1094107phenazopyridine HCl 100 MG Oral TabletPSNf6829698-b12e-484d-a322-d2f68586e63711
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDf6829698-b12e-484d-a322-d2f68586e63711
1094107phenazopyridine HCl 100 MG Oral TabletPSN132cc592-6b03-4b75-bf39-df476fb9dc816
1094107phenazopyridine HCl 100 MG Oral TabletPSNd1f4ec5c-ca63-7ccd-e053-2a95a90a0db76
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD132cc592-6b03-4b75-bf39-df476fb9dc816
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDd1f4ec5c-ca63-7ccd-e053-2a95a90a0db76
1094107phenazopyridine HCl 100 MG Oral TabletPSN7aae87e6-92be-4e66-aca1-5be7f24a8c2d4
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD7aae87e6-92be-4e66-aca1-5be7f24a8c2d4
1094107phenazopyridine HCl 100 MG Oral TabletPSNbd0ae1dc-f170-eda6-e053-2995a90a6c9b3
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDbd0ae1dc-f170-eda6-e053-2995a90a6c9b3
1094107phenazopyridine HCl 100 MG Oral TabletPSNf29f2ed6-6fd1-fd65-e053-2a95a90aedc42
1094107phenazopyridine HCl 100 MG Oral TabletPSNf40ea909-9df7-c90a-e053-2995a90a29872
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDf29f2ed6-6fd1-fd65-e053-2a95a90aedc42
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDf40ea909-9df7-c90a-e053-2995a90a29872
1094107phenazopyridine HCl 100 MG Oral TabletPSNb7a5da89-dc52-4b61-8a54-262d0826c6351
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDb7a5da89-dc52-4b61-8a54-262d0826c6351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-681-1065162068110100 TABLET in 1 BOTTLE (65162-681-10) 100 tablet2011-02-010000-00-00NoNoCurrent