Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acamprosate calcium
Product Details
NDC Product Code
68382-569Application Number
ANDA205995Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 6, 2023AcamprosateActive
Code: 59375N1D0UClass: ACTIBQuantity: 333 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT