UroAv-81
UroAv-81 Tablets (Product contract packaged by Apace Packaging, LLC)
Approved
Approval ID
6cbeb7be-397b-819f-e053-2a91aa0a208e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2018
Manufacturers
FDA
Apace Packaging, LLC
DUNS: 361961142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15338-502
Product Classification
G
Generic Name
Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2018
FDA Product Classification
INGREDIENTS (11)
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHENAMINEActive
Quantity: 81 mg in 1 1
Code: J50OIX95QV
Classification: ACTIB
PHENYL SALICYLATEActive
Quantity: 32.4 mg in 1 1
Code: 28A37T47QO
Classification: ACTIB
METHYLENE BLUEActive
Quantity: 10.8 mg in 1 1
Code: T42P99266K
Classification: ACTIB
HYOSCYAMINE SULFATEActive
Quantity: 0.12 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSActive
Quantity: 40.8 mg in 1 1
Code: KH7I04HPUU
Classification: ACTIB