FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
82804-994
11-digit product format
828040994
Labeler code
82804
Product ID
82804-994_ac155091-ee07-46da-bb25-ff4cd4074610
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
Rxcui1094104, 1094107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-994-00Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET1001
82804-994-06Phenazopyridine Hydrochloride6 in 1 BOTTLETABLET61
82804-994-10Phenazopyridine Hydrochloride10 in 1 BOTTLETABLET101
82804-994-12Phenazopyridine Hydrochloride12 in 1 BOTTLETABLET121
82804-994-20Phenazopyridine Hydrochloride20 in 1 BOTTLETABLET201
82804-994-24Phenazopyridine Hydrochloride24 in 1 BOTTLETABLET241
82804-994-55Phenazopyridine Hydrochloride500 in 1 BOTTLETABLET5001
82804-994-90Phenazopyridine Hydrochloride90 in 1 BOTTLETABLET901
82804-994-96Phenazopyridine Hydrochloride96 in 1 BOTTLETABLET961

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-994-00EA - Each82804-994c69af74b-aada-4984-aab7-a5c0c3d2e83f12024-06-10
82804-994-06EA - Each82804-9947e615ad2-bfce-432f-a33e-077430eecdfe12024-06-10
82804-994-10EA - Each82804-994ee86ba0a-b059-4959-a567-59f9d4b44bca12024-06-10
82804-994-12EA - Each82804-994fa3757e2-d2c5-4303-80b5-f54fe559952a12024-06-10
82804-994-20EA - Each82804-994c2e498f9-f709-47d5-8c10-9384df682db612024-06-10
82804-994-24EA - Each82804-9943ce33e7b-9adf-4ea8-9b46-3303c1b71ef512024-06-10
82804-994-55EA - Each82804-994de59334f-70cb-43ba-9bfa-5bdd53133be812024-06-10
82804-994-90EA - Each82804-994e76e6e8e-118b-446d-adc2-ef798d155e5012024-06-10
82804-994-96EA - Each82804-9945dac90a5-972f-46de-9465-086e33fb500712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-994PHENAZOPYRIDINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 9 package rows20240508_ac155091-ee07-46da-bb25-ff4cd4074610.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094107phenazopyridine HCl 100 MG Oral TabletPSNac155091-ee07-46da-bb25-ff4cd40746101
1094104phenazopyridine HCl 200 MG Oral TabletPSNac155091-ee07-46da-bb25-ff4cd40746101
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDac155091-ee07-46da-bb25-ff4cd40746101
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDac155091-ee07-46da-bb25-ff4cd40746101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-994-0082804099400100 TABLET in 1 BOTTLE (82804-994-00) 100 tablet2024-05-06NoNoCurrent
82804-994-06828040994066 TABLET in 1 BOTTLE (82804-994-06) 6 tablet2024-05-06NoNoCurrent
82804-994-108280409941010 TABLET in 1 BOTTLE (82804-994-10) 10 tablet2024-05-06NoNoCurrent
82804-994-128280409941212 TABLET in 1 BOTTLE (82804-994-12) 12 tablet2024-05-06NoNoCurrent
82804-994-208280409942020 TABLET in 1 BOTTLE (82804-994-20) 20 tablet2024-05-06NoNoCurrent
82804-994-248280409942424 TABLET in 1 BOTTLE (82804-994-24) 24 tablet2024-05-06NoNoCurrent
82804-994-5582804099455500 TABLET in 1 BOTTLE (82804-994-55) 500 tablet2024-05-06NoNoCurrent
82804-994-908280409949090 TABLET in 1 BOTTLE (82804-994-90) 90 tablet2024-05-06NoNoCurrent
82804-994-968280409949696 TABLET in 1 BOTTLE (82804-994-96) 96 tablet2024-05-06NoNoCurrent