Phenazopyridine Hydrochloride

Product NDC
68788-8668
Requested package NDC
68788-8668-2
11-digit product format
687888668
Labeler code
68788
Product ID
68788-8668_80b0692c-612b-4724-92bc-9dd2e30501fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-05-20
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8668-1Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET152
68788-8668-6Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8668-1EA - Each68788-86687fe690ca-b02e-4d32-a5ff-eb79874fb4bd12024-07-12
68788-8668-6EA - Each68788-866885a70815-1952-42e7-8d31-1c532fffacb212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8668PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240524_ce702be2-eec2-4346-965e-f1f6ba342fc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSNce702be2-eec2-4346-965e-f1f6ba342fc92
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDce702be2-eec2-4346-965e-f1f6ba342fc92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8668-26878886680212 TABLET in 1 BOTTLE (68788-8668-2) 12 tablet2024-05-20NoNoCurrent