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Phenazopyridine Hydrochloride

PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

Approved
Approval ID

132cc592-6b03-4b75-bf39-df476fb9dc81

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 25, 2023

Manufacturers
FDA

Preferred Pharmaceuticals Inc.

DUNS: 791119022

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 Code68788-7981
Product Classification
G
Generic Name
Phenazopyridine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 25, 2023
FDA Product Classification

INGREDIENTS (9)

PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Phenazopyridine Hydrochloride - FDA Drug Approval Details