Phenazopyridine Hydrochloride
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only
Approved
Approval ID
65346b3f-7a71-4b35-84c8-385ded952867
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2023
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 Code51293-611
Product Classification
G
Generic Name
Phenazopyridine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2023
FDA Product Classification
INGREDIENTS (15)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Phenazopyridine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-612
Product Classification
G
Generic Name
Phenazopyridine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2023
FDA Product Classification
INGREDIENTS (15)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 7/1/2021
Manufactured by:
ECI Pharmaceuticals, LLC
Fort Lauderdale, FL 33309
Rev. 03-2020