Campral
These highlights do not include all the information needed to use CAMPRAL safely and effectively. See full prescribing information for CAMPRAL. CAMPRAL® (acamprosate calcium) Delayed-Release Tablets Initial U.S. Approval: 2004
Approved
Approval ID
fe6f754f-62b4-4c86-805d-221332409516
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-4760
Application NumberNDA021431
Product Classification
M
Marketing Category
C73594
G
Generic Name
acamprosate calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2012
FDA Product Classification
INGREDIENTS (10)
acamprosate calciumActive
Quantity: 333 mg in 1 1
Code: 59375N1D0U
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT