FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
42937-702
Requested package NDC
42937-702-16
11-digit product format
429370702
Labeler code
42937
Product ID
42937-702_edc15341-9bca-4088-8e91-668e7c66ae25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Nationwide Laboratories, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-02
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 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 packagepackage42937-70242937-702-16DDiscontinued by firm2026-10-05

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
42937-702-102020-03-03Phenazopyridine Hydrochloride Tablets, USP
42937-702-162020-03-03Phenazopyridine Hydrochloride Tablets, USP
42937-702-102020-01-31Phenazopyridine Hydrochloride Tablets, USP
42937-702-162020-01-31Phenazopyridine Hydrochloride Tablets, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phenazopyridine HydrochlorideACTIVE INGREDIENT0EWG668W17PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
PhenazopyridineACTIVE MOIETYK2J09EMJ52PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UPHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOPHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPPHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
PovidonesINACTIVE INGREDIENTFZ989GH94EPHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED [NATIONWIDE LABORATORIES, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN4ec9b358-f3d7-3eb5-e054-00144ff88e883
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD4ec9b358-f3d7-3eb5-e054-00144ff88e883
1094104phenazopyridine HCl 200 MG Oral TabletPSN8ee8c0a7-ba7a-27b0-e053-2a95a90a186a2
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD8ee8c0a7-ba7a-27b0-e053-2a95a90a186a2
1094104phenazopyridine HCl 200 MG Oral TabletPSN267a6c21-70ea-24cd-e054-00144ff8d46c1
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD267a6c21-70ea-24cd-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42937-702-1642937070216250 TABLET, COATED in 1 BOTTLE (42937-702-16) 2011-08-020000-00-00NoNoCurrent