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Phenazopyridine Hydrochloride

PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

Approved
Approval ID

f40e173c-907a-648c-e053-2a95a90a9c87

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 6, 2023

Manufacturers
FDA

Redpharm Drug, Inc.

DUNS: 828374897

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Phenazopyridine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67296-1447
Product Classification
G
Generic Name
Phenazopyridine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 6, 2023
FDA Product Classification

INGREDIENTS (9)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB

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Phenazopyridine Hydrochloride - FDA Drug Approval Details