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 Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094104, 1094107

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

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