FDA.reportPublic FDA data

Acamprosate Calcium

Product NDC
0378-6333
11-digit product format
003786333
Labeler code
0378
Product ID
0378-6333_e06868f1-f40b-4762-bd52-53a5ba825619
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acamprosate calcium enteric-coated
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA200142
Marketing category
ANDA
Marketing start
2014-09-24
Substance
ACAMPROSATE CALCIUM
Active strength
333 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acamprosate Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACAMPROSATE CALCIUM333 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii59375N1D0U
Rxcui835726

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c95d5956-8a83-9dba-bb9d-d7b5fb3324ecProduct name320170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-6333-80Acamprosate Calcium180 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE18012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6333-80EA - Each0378-63336eeea4d4-e974-490e-9718-abc891d9771712014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACAMPROSATE CALCIUMACTIVE INGREDIENT59375N1D0UACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
ACAMPROSATEACTIVE MOIETYN4K14YGM3JACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6333ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED) TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 1 package rows20250115_75ddfd10-55b2-426e-bc74-3413cd0d7c94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSN75ddfd10-55b2-426e-bc74-3413cd0d7c9412
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCD75ddfd10-55b2-426e-bc74-3413cd0d7c9412
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSY75ddfd10-55b2-426e-bc74-3413cd0d7c9412
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSNf2bf6742-4b85-45e2-8daa-0f9bfc75a1281
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCDf2bf6742-4b85-45e2-8daa-0f9bfc75a1281
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSYf2bf6742-4b85-45e2-8daa-0f9bfc75a1281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-6333-8000378633380180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80) 2014-09-240000-00-00NoNoCurrent