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Phenazopyridine Hydrochloride

PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx Only

Approved
Approval ID

ac140b94-1846-7b88-e053-2995a90ae3f2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 7, 2020

Manufacturers
FDA

Skya Health, LLC

DUNS: 117039304

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 Code73086-101
Product Classification
G
Generic Name
Phenazopyridine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2020
FDA Product Classification

INGREDIENTS (9)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB

Phenazopyridine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73086-102
Product Classification
G
Generic Name
Phenazopyridine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2020
FDA Product Classification

INGREDIENTS (9)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PHENAZOPYRIDINE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 0EWG668W17
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/4/2015

DOSAGE AND ADMINISTRATION

100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.

200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals.

When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine HCl should not exceed 2 days.

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Phenazopyridine Hydrochloride - FDA Drug Approval Details