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FDA Approval

Ustell

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Star Pharmaceuticals LLC

DUNS: 962184003

Effective Date

January 10, 2017

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hexamethylenetetramine(120 mg in 1 1)

Sodium phosphate, dibasic(40.8 mg in 1 1)

Phenyl salicylate(36 mg in 1 1)

Methylene blue(10 mg in 1 1)

Hyoscyamine(0.12 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ustell

Product Details

NDC Product Code

0076-0903

Route of Administration

ORAL

Effective Date

January 10, 2017

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HexamethylenetetramineActive

Code: J50OIX95QVClass: ACTIBQuantity: 120 mg in 1 1

Sodium phosphate, dibasicActive

Code: 593YOG76RNClass: ACTIBQuantity: 40.8 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Phenyl salicylateActive

Code: 28A37T47QOClass: ACTIBQuantity: 36 mg in 1 1

Methylene blueActive

Code: T42P99266KClass: ACTIBQuantity: 10 mg in 1 1

HyoscyamineActive

Code: F2R8V82B84Class: ACTIBQuantity: 0.12 mg in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

WARNINGS SECTION

WARNINGS

Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue use immediately.

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