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
9803db35-2600-4f42-80c1-43216fd1ba3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
Zydus Pharmaceuticals (USA) Inc.
DUNS: 156861945
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acamprosate calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-569
Application NumberANDA205995
Product Classification
M
Marketing Category
C73584
G
Generic Name
acamprosate calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2023
FDA Product Classification
INGREDIENTS (11)
ACAMPROSATE CALCIUMActive
Quantity: 333 mg in 1 1
Code: 59375N1D0U
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT