Acamprosate Calcium

Product NDC
60687-121
11-digit product format
606870121
Labeler code
60687
Product ID
60687-121_3d49a773-bfca-9870-e063-6294a90a2945
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acamprosate Calcium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA202229
Marketing category
ANDA
Marketing start
2015-10-27
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
60687-121-25Acamprosate Calcium30 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE3011
60687-121-95Acamprosate Calcium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-121ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20241003_94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSN94ef2a5c-cc2f-4e7f-b159-b2d38188d5b811
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCD94ef2a5c-cc2f-4e7f-b159-b2d38188d5b811
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSY94ef2a5c-cc2f-4e7f-b159-b2d38188d5b811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-121-256068701212530 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-121-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-121-95) 30 blister pack2015-10-270000-00-00NoNoCurrent
60687-121-95606870121951 in 1 BLISTER PACKHistorical