Phenazopyridine Hydrochloride
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rev 12/21 Rx Only CAUTION: Federal law prohibits dispensing without prescription
Approved
Approval ID
0a190e86-4074-4822-888e-4952281712ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2022
Manufacturers
FDA
Winder Laboratories, LLC
DUNS: 965195170
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenazopyridine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-115
Product Classification
G
Generic Name
Phenazopyridine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (9)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB
Phenazopyridine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-114
Product Classification
G
Generic Name
Phenazopyridine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (9)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT