FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
68788-8695
11-digit product format
687888695
Labeler code
68788
Product ID
68788-8695_9031f9a7-3b0c-406e-a76f-a654a4dca6d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-06-11
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE200 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8695-1Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET152
68788-8695-9Phenazopyridine Hydrochloride9 in 1 BOTTLETABLET92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8695-1EA - Each68788-8695380246d1-2063-43ba-8b91-59d0717d56fd12024-08-12
68788-8695-9EA - Each68788-8695ca424115-8aeb-4b52-82a2-3f82b84f408a12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8695PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC]1Current NDC, 2 package rows20240619_96308f8c-66e7-486a-a5c0-ee9a133ad051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN96308f8c-66e7-486a-a5c0-ee9a133ad0512
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD96308f8c-66e7-486a-a5c0-ee9a133ad0512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8695-16878886950115 TABLET in 1 BOTTLE (68788-8695-1) 15 tablet2024-06-11NoNoCurrent
68788-8695-26878886950212 TABLET in 1 BOTTLE (68788-8695-2) 12 tablet2024-06-11NoNoCurrent
68788-8695-5687888695055 TABLET in 1 BOTTLE (68788-8695-5) 5 tablet2024-06-11NoNoCurrent
68788-8695-9687888695099 TABLET in 1 BOTTLE (68788-8695-9) 9 tablet2024-06-11NoNoCurrent