FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
69367-611
11-digit product format
693670611
Labeler code
69367
Product ID
69367-611_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
100 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 HYDROCHLORIDE100 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
69367-611-01Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-611-01EA - Each69367-611f35fa1bb-43cc-4f2e-8e9d-e8633fbaf9ae12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-611PHENAZOPYRIDINE 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
1094107phenazopyridine HCl 100 MG Oral TabletPSN25a1d5cf-7ede-4ece-8ec9-ccf979355d98101
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD25a1d5cf-7ede-4ece-8ec9-ccf979355d98101
1094107phenazopyridine HCl 100 MG Oral TabletPSN49baf6e5-133a-4e1a-9740-506673d27caf5
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD49baf6e5-133a-4e1a-9740-506673d27caf5
1094107phenazopyridine HCl 100 MG Oral TabletPSN10cd6fad-1923-ad00-e063-6394a90a95542
1094107phenazopyridine HCl 100 MG Oral TabletPSNce702be2-eec2-4346-965e-f1f6ba342fc92
1094107phenazopyridine HCl 100 MG Oral TabletPSN140a40f8-26ec-46ac-a04b-998ea96e8f932
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD140a40f8-26ec-46ac-a04b-998ea96e8f932
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDce702be2-eec2-4346-965e-f1f6ba342fc92
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD10cd6fad-1923-ad00-e063-6394a90a95542
1094107phenazopyridine HCl 100 MG Oral TabletPSN20681450-859a-45b0-825c-760cbbd95ac61
1094107phenazopyridine HCl 100 MG Oral TabletPSN4972da43-5ed3-d210-e063-6394a90acb871
1094107phenazopyridine HCl 100 MG Oral TabletPSN7e0f2ba8-003c-4303-80fd-76f70ddc2c111
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
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD20681450-859a-45b0-825c-760cbbd95ac61
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD4972da43-5ed3-d210-e063-6394a90acb871
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD7e0f2ba8-003c-4303-80fd-76f70ddc2c111
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 TabletSCDac155091-ee07-46da-bb25-ff4cd40746101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-611-0169367061101100 TABLET in 1 BOTTLE (69367-611-01) 100 tablet2023-10-19NoNoCurrent