FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
70518-3975
11-digit product format
705183975
Labeler code
70518
Product ID
70518-3975_521805ce-3630-8dc7-e063-6294a90ad5e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-06
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenazopyridine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094104

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3975-0Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3975-1Phenazopyridine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET217
70518-3975-2Phenazopyridine Hydrochloride9 in 1 BOTTLE, PLASTICTABLET97
70518-3975-3Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET67
70518-3975-4Phenazopyridine Hydrochloride50 in 1 BOXTABLET507
70518-3975-5Phenazopyridine Hydrochloride1 in 1 POUCHTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3975PHENAZOPYRIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 6 package rows20240123_6eb59b69-4ad0-47b1-bd3c-1d04d0852ec5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN6eb59b69-4ad0-47b1-bd3c-1d04d0852ec57
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD6eb59b69-4ad0-47b1-bd3c-1d04d0852ec57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3975-07051839750030 TABLET in 1 BLISTER PACK (70518-3975-0) 30 tablet2024-01-06NoNoHistorical
70518-3975-17051839750121 in 1 BOTTLE, PLASTICHistorical
70518-3975-2705183975029 TABLET in 1 BOTTLE, PLASTIC (70518-3975-2) 9 tablet2025-11-01NoNoHistorical
70518-3975-3705183975036 TABLET in 1 BOTTLE, PLASTIC (70518-3975-3) 6 tablet2026-05-13NoNoHistorical
70518-3975-47051839750450 POUCH in 1 BOX (70518-3975-4) / 1 TABLET in 1 POUCH (70518-3975-5) 50 pouch2026-05-14NoNoHistorical
70518-3975-5705183975051 in 1 POUCHHistorical