FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
50090-6952
11-digit product format
500906952
Labeler code
50090
Product ID
50090-6952_ba94af0c-ff74-484c-9a83-21e4dacb15a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-19
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
50090-6952-0Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET106
50090-6952-1Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET156
50090-6952-4Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET66
50090-6952-6Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET126
50090-6952-7Phenazopyridine Hydrochloride9 in 1 BOTTLETABLET96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6952-0EA - Each50090-6952eefc9558-fddc-4979-8482-186d250c27b212024-02-14
50090-6952-1EA - Each50090-6952c36d2d1d-0dc2-4fcf-89b5-4f2e915413fc12024-02-14
50090-6952-4EA - Each50090-695200dadd0b-cb4a-42bf-a112-77ca4745c24412024-02-14
50090-6952-6EA - Each50090-6952f1185a3d-e464-4b81-99ed-12db259876cc12024-02-14
50090-6952-7EA - Each50090-695291f97dc7-36e5-42c5-93d8-bfab3525507712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6952PHENAZOPYRIDINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 5 package rows20241018_cd78a132-037c-412a-9c56-e38367e05c92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNcd78a132-037c-412a-9c56-e38367e05c926
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDcd78a132-037c-412a-9c56-e38367e05c926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6952-05009069520010 TABLET in 1 BOTTLE (50090-6952-0) 10 tablet2023-12-19NoNoHistorical
50090-6952-15009069520115 TABLET in 1 BOTTLE (50090-6952-1) 15 tablet2023-12-19NoNoHistorical
50090-6952-4500906952046 TABLET in 1 BOTTLE (50090-6952-4) 6 tablet2023-12-19NoNoHistorical
50090-6952-65009069520612 TABLET in 1 BOTTLE (50090-6952-6) 12 tablet2023-12-19NoNoHistorical
50090-6952-7500906952079 TABLET in 1 BOTTLE (50090-6952-7) 9 tablet2023-12-19NoNoHistorical