Acamprosate Calcium
These highlights do not include all the information needed to use ACAMPROSATE CALCIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for ACAMPROSATE CALCIUM DELAYED-RELEASE TABLETS. ACAMPROSATE CALCIUM delayed-release tablets, for oral useInitial U.S. Approval: 2004
Approved
Approval ID
75ddfd10-55b2-426e-bc74-3413cd0d7c94
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acamprosate calcium enteric-coated
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-6333
Application NumberANDA200142
Product Classification
M
Marketing Category
C73584
G
Generic Name
acamprosate calcium enteric-coated
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2014
FDA Product Classification
INGREDIENTS (12)
ACAMPROSATE CALCIUMActive
Quantity: 333 mg in 1 1
Code: 59375N1D0U
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT