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FDA Approval

Uretron D/S

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

FDA Approval Summary

Company
A.G. Marin Pharmaceutical
DUNS: 076007996
Effective Date
October 7, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hexamethylenetetramine(81.6 mg in 1 1)
Phenyl salicylate(36.2 mg in 1 1)
Methylene blue(10.8 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.

Uretron D/S

Product Details

NDC Product Code
12539-144
Route of Administration
ORAL
Effective Date
October 7, 2022
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: J50OIX95QVClass: ACTIBQuantity: 81.6 mg in 1 1
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: 593YOG76RNClass: ACTIBQuantity: 40.8 mg in 1 1
Code: 28A37T47QOClass: ACTIBQuantity: 36.2 mg in 1 1
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: T42P99266KClass: ACTIBQuantity: 10.8 mg in 1 1
Code: F2R8V82B84Class: ACTIBQuantity: 0.12 mg in 1 1
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