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
43e9ef60-2d85-4394-906b-93042fea099a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2020
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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 Code68462-435
Application NumberANDA202229
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acamprosate Calcium
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ACAMPROSATE CALCIUMActive
Quantity: 333 mg in 1 1
Code: 59375N1D0U
Classification: ACTIB
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT