Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Unique Pharmaceutical Laboratories
Rising Pharma Holdings, Inc.
650434645
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxybutynin Chloride Extended Release
Product Details
NDC Product Code
64980-210Application Number
ANDA206121Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 29, 2022POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810YClass: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70OClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Oxybutynin Chloride Extended Release
Product Details
NDC Product Code
64980-211Application Number
ANDA206121Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 29, 2022OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 15 mg in 1 1
POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810YClass: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70OClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Oxybutynin Chloride Extended Release
Product Details
NDC Product Code
64980-209Application Number
ANDA206121Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 29, 2022HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70OClass: IACT
OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810YClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT