FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
71205-813
11-digit product format
712050813
Labeler code
71205
Product ID
71205-813_e018e176-c4ec-42a2-9119-f1278cfa719a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094104

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-813-06Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET61
71205-813-10Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET101
71205-813-12Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET121
71205-813-20Phenazopyridine Hydrochloride20 in 1 BOTTLETABLET201
71205-813-24Phenazopyridine Hydrochloride24 in 1 BOTTLETABLET241
71205-813-30Phenazopyridine Hydrochloride30 in 1 BOTTLETABLET301
71205-813-60Phenazopyridine Hydrochloride60 in 1 BOTTLETABLET601
71205-813-90Phenazopyridine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-813-06EA - Each71205-813bb7783d5-6834-4f87-8d49-c2b5ea41bc5112025-05-14
71205-813-12EA - Each71205-813a93a6570-2a1f-40b1-843b-61c2e158c55612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-813PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [PROFICIENT RX LP]1Current NDC, 8 package rows20230623_e018e176-c4ec-42a2-9119-f1278cfa719a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNe018e176-c4ec-42a2-9119-f1278cfa719a1
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDe018e176-c4ec-42a2-9119-f1278cfa719a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-813-06712050813066 TABLET in 1 BOTTLE (71205-813-06) 6 tablet2023-06-14NoNoHistorical
71205-813-107120508131010 TABLET in 1 BOTTLE (71205-813-10) 10 tablet2023-06-14NoNoHistorical
71205-813-127120508131212 TABLET in 1 BOTTLE (71205-813-12) 12 tablet2023-06-14NoNoHistorical
71205-813-207120508132020 TABLET in 1 BOTTLE (71205-813-20) 20 tablet2023-06-14NoNoHistorical
71205-813-247120508132424 TABLET in 1 BOTTLE (71205-813-24) 24 tablet2023-06-14NoNoHistorical
71205-813-307120508133030 TABLET in 1 BOTTLE (71205-813-30) 30 tablet2023-06-14NoNoHistorical
71205-813-607120508136060 TABLET in 1 BOTTLE (71205-813-60) 60 tablet2023-06-14NoNoHistorical
71205-813-907120508139090 TABLET in 1 BOTTLE (71205-813-90) 90 tablet2023-06-14NoNoHistorical