Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
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Product Details
NDC Product Code
46122-620Application Number
ANDA209837Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 8, 2025LoperamideActive
Code: 77TI35393CClass: ACTIBQuantity: 2 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
DimethiconeActive
Code: 92RU3N3Y1OClass: ACTIBQuantity: 125 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT