FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
69367-612
11-digit product format
693670612
Labeler code
69367
Product ID
69367-612_6f4d2d9d-4389-4d76-9f5e-e004d7b09a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094104Internal RxNorm lookup
1094107Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
20681450-859a-45b0-825c-760cbbd95ac6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-612-01Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-612-01EA - Each69367-612d393d23f-ffaf-4801-ac83-d88004d6bcdb12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-612PHENAZOPYRIDINE HYDROCHLORIDE TABLET [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20231101_20681450-859a-45b0-825c-760cbbd95ac6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC20681450-859a-45b0-825c-760cbbd95ac62023-10-31Warnings, Adverse reactionsExact identifier
ndc (product): 69367-612

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN24786685-978b-4485-995a-2964802bc262101
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD24786685-978b-4485-995a-2964802bc262101
1094104phenazopyridine HCl 200 MG Oral TabletPSN6eb59b69-4ad0-47b1-bd3c-1d04d0852ec57
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD6eb59b69-4ad0-47b1-bd3c-1d04d0852ec57
1094104phenazopyridine HCl 200 MG Oral TabletPSNcd78a132-037c-412a-9c56-e38367e05c926
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDcd78a132-037c-412a-9c56-e38367e05c926
1094104phenazopyridine HCl 200 MG Oral TabletPSN6c3adf9f-7179-43b7-8397-4148a9146a2c4
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD6c3adf9f-7179-43b7-8397-4148a9146a2c4
1094104phenazopyridine HCl 200 MG Oral TabletPSNd514fd31-feeb-4371-9b28-eec9834a70033
1094104phenazopyridine HCl 200 MG Oral TabletPSN0e34badf-c886-08c1-e063-6294a90aeefd3
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDd514fd31-feeb-4371-9b28-eec9834a70033
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD0e34badf-c886-08c1-e063-6294a90aeefd3
1094104phenazopyridine HCl 200 MG Oral TabletPSN96308f8c-66e7-486a-a5c0-ee9a133ad0512
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD96308f8c-66e7-486a-a5c0-ee9a133ad0512
1094107phenazopyridine HCl 100 MG Oral TabletPSN20681450-859a-45b0-825c-760cbbd95ac61
1094107phenazopyridine HCl 100 MG Oral TabletPSNac155091-ee07-46da-bb25-ff4cd40746101
1094104phenazopyridine HCl 200 MG Oral TabletPSN20681450-859a-45b0-825c-760cbbd95ac61
1094104phenazopyridine HCl 200 MG Oral TabletPSNac155091-ee07-46da-bb25-ff4cd40746101
1094104phenazopyridine HCl 200 MG Oral TabletPSN1e1a997a-9204-441c-e063-6294a90a503e1
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD20681450-859a-45b0-825c-760cbbd95ac61
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDac155091-ee07-46da-bb25-ff4cd40746101
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD20681450-859a-45b0-825c-760cbbd95ac61
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD1e1a997a-9204-441c-e063-6294a90a503e1
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDac155091-ee07-46da-bb25-ff4cd40746101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-612-0169367061201100 TABLET in 1 BOTTLE (69367-612-01) 100 tablet2023-10-19NoNoCurrent