Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
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
60687-121Application Number
ANDA202229Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 28, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9Class: IACT
AcamprosateActive
Code: 59375N1D0UClass: ACTIBQuantity: 333 mg in 1 1
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT