Acamprosate Calcium

Product NDC
10135-636
11-digit product format
101350636
Labeler code
10135
Product ID
10135-636_c9c9c07d-25f5-40e2-b40a-1d1942dd640a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acamprosate Calcium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA202229
Marketing category
ANDA
Marketing start
2016-08-01
Marketing end
0000-00-00
Substance
ACAMPROSATE CALCIUM
Active strength
333 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-636-32Acamprosate Calcium180 in 1 BOTTLETABLET, DELAYED RELEASE1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-636ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 1 package rows20191112_a815699f-90ee-41ba-838c-11951aeda90f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835726acamprosate calcium 333 MG Delayed Release Oral TabletPSNa815699f-90ee-41ba-838c-11951aeda90f3
835726acamprosate calcium 333 MG Delayed Release Oral TabletSCDa815699f-90ee-41ba-838c-11951aeda90f3
835726acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral TabletSYa815699f-90ee-41ba-838c-11951aeda90f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-636-3210135063632180 in 1 BOTTLEHistorical