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 Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094104, 1094107

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

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