FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
51293-810
Requested package NDC
51293-810-01
11-digit product format
512930810
Labeler code
51293
Product ID
51293-810_1c1118af-aafb-40a7-9967-13751b416918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
ECI Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51293-81051293-810-01DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51293-810-012026-01-22C16284748780-1d6a99b39-9b39-a426-e053-dadaa90af4c2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
51293-810-012022-01-28C16284748780-1d6a99b39-9b39-a426-e053-dadaa90af4c2PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51293-810-01EA - Each51293-810a40e0a1a-0dd7-4431-952b-fb7cad7c81af12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENAZOPYRIDINE HYDROCHLORIDEACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
PHENAZOPYRIDINEACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51293-810PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [ECI PHARMACEUTICALS, LLC]6Legacy NDC20201228_c2049b62-04d7-44a4-968c-a1e7fccb0125.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSNb4d22d69-b225-46b8-84a1-52321bb888041
1094104phenazopyridine HCl 200 MG Oral TabletPSNb4d22d69-b225-46b8-84a1-52321bb888041
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDb4d22d69-b225-46b8-84a1-52321bb888041
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDb4d22d69-b225-46b8-84a1-52321bb888041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51293-810-0151293081001100 TABLET in 1 BOTTLE (51293-810-01) 100 tablet2011-02-010000-00-00NoNoCurrent