Phenazopyridine Hydrochloride
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
Approved
Approval ID
c2049b62-04d7-44a4-968c-a1e7fccb0125
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2020
Manufacturers
FDA
ECI Pharmaceuticals, LLC
DUNS: 962476029
Products 2
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 Code51293-810
Product Classification
G
Generic Name
Phenazopyridine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Phenazopyridine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-811
Product Classification
G
Generic Name
Phenazopyridine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (9)
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT