FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
50090-5876
11-digit product format
500905876
Labeler code
50090
Product ID
50090-5876_ab18cf45-4c1d-4d6a-9195-e70ad6e0cd68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5876-02025-09-05C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-12025-09-05C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-42025-09-05C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-52025-09-05C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-62025-09-05C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-72025-09-05C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-82025-09-05C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-02024-01-30C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-12024-01-30C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-42024-01-30C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-52024-01-30C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-62024-01-30C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-72024-01-30C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
50090-5876-82024-01-30C16284748780-11030e365-2f87-111a-e063-dadaa90a10e2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5876-0Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET106
50090-5876-1Phenazopyridine Hydrochloride15 in 1 BOTTLETABLET156
50090-5876-4Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET66
50090-5876-5Phenazopyridine Hydrochloride60 in 1 BOTTLETABLET606
50090-5876-6Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET126
50090-5876-7Phenazopyridine Hydrochloride9 in 1 BOTTLETABLET96
50090-5876-8Phenazopyridine Hydrochloride21 in 1 BOTTLETABLET216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5876-0EA - Each50090-5876bd7f66b3-072e-4b92-a64c-48ef0dfdbcf312022-06-06
50090-5876-1EA - Each50090-5876ba251509-1aaa-4a51-ad84-f23f816d6a4412022-06-06
50090-5876-4EA - Each50090-5876dc3f11ae-6547-421e-8c4c-901e5c6e1e2812022-06-06
50090-5876-6EA - Each50090-58766dbd4c30-9b12-4901-8f15-2a6b6d79b5de12022-06-06
50090-5876-7EA - Each50090-58763665c99c-ce1d-4695-9649-adfdc4290ff512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5876PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 7 package rows20220121_d8155f91-d650-4021-91ee-f3b6c1055a36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSNd8155f91-d650-4021-91ee-f3b6c1055a366
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDd8155f91-d650-4021-91ee-f3b6c1055a366

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5876-05009058760010 TABLET in 1 BOTTLE (50090-5876-0) 10 tablet2021-12-170000-00-00NoNoCurrent
50090-5876-15009058760115 TABLET in 1 BOTTLE (50090-5876-1) 15 tablet2022-01-200000-00-00NoNoCurrent
50090-5876-4500905876046 TABLET in 1 BOTTLE (50090-5876-4) 6 tablet2022-01-200000-00-00NoNoCurrent
50090-5876-55009058760560 TABLET in 1 BOTTLE (50090-5876-5) 60 tablet2021-12-170000-00-00NoNoCurrent
50090-5876-65009058760612 TABLET in 1 BOTTLE (50090-5876-6) 12 tablet2022-01-200000-00-00NoNoCurrent
50090-5876-7500905876079 TABLET in 1 BOTTLE (50090-5876-7) 9 tablet2022-01-200000-00-00NoNoCurrent
50090-5876-85009058760821 TABLET in 1 BOTTLE (50090-5876-8) 21 tablet2021-12-170000-00-00NoNoCurrent