FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
82804-047
11-digit product format
828040047
Labeler code
82804
Product ID
82804-047_8c3cb5d2-5e01-4f80-a8b8-70802ac0c8d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
Rxcui1094107

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
82804-047-06Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET62
82804-047-10Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET102
82804-047-12Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET122
82804-047-18Phenazopyridine Hydrochloride18 in 1 BOTTLETABLET182
82804-047-20Phenazopyridine Hydrochloride20 in 1 BOTTLETABLET202
82804-047-24Phenazopyridine Hydrochloride24 in 1 BOTTLETABLET242
82804-047-30Phenazopyridine Hydrochloride30 in 1 BOTTLETABLET302
82804-047-60Phenazopyridine Hydrochloride60 in 1 BOTTLETABLET602
82804-047-90Phenazopyridine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-047-12EA - Each82804-047384ac9fc-13a7-4e98-ae80-91007f9895df12024-02-14
82804-047-18EA - Each82804-047794418cc-b568-4d37-a4b7-54ffbf5f5c8312024-04-05
82804-047-20EA - Each82804-0478f01b7b7-140a-464d-9ab5-96e4d16c501812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-047PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, 9 package rows20240216_140a40f8-26ec-46ac-a04b-998ea96e8f93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSN140a40f8-26ec-46ac-a04b-998ea96e8f932
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCD140a40f8-26ec-46ac-a04b-998ea96e8f932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-047-06828040047066 TABLET in 1 BOTTLE (82804-047-06) 6 tablet2023-12-20NoNoCurrent
82804-047-108280400471010 TABLET in 1 BOTTLE (82804-047-10) 10 tablet2023-12-20NoNoCurrent
82804-047-128280400471212 TABLET in 1 BOTTLE (82804-047-12) 12 tablet2023-12-20NoNoCurrent
82804-047-188280400471818 TABLET in 1 BOTTLE (82804-047-18) 18 tablet2024-02-14NoNoCurrent
82804-047-208280400472020 TABLET in 1 BOTTLE (82804-047-20) 20 tablet2023-12-20NoNoCurrent
82804-047-248280400472424 TABLET in 1 BOTTLE (82804-047-24) 24 tablet2023-12-20NoNoCurrent
82804-047-308280400473030 TABLET in 1 BOTTLE (82804-047-30) 30 tablet2023-12-20NoNoCurrent
82804-047-608280400476060 TABLET in 1 BOTTLE (82804-047-60) 60 tablet2023-12-20NoNoCurrent
82804-047-908280400479090 TABLET in 1 BOTTLE (82804-047-90) 90 tablet2023-12-20NoNoCurrent