NDC 0093-5352

Acamprosate Calcium

Acamprosate Calcium

Acamprosate Calcium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Acamprosate Calcium.

Product ID0093-5352_04f7b937-327d-4ba3-a61d-bfcd82ef5950
NDC0093-5352
Product TypeHuman Prescription Drug
Proprietary NameAcamprosate Calcium
Generic NameAcamprosate Calcium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA200143
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameACAMPROSATE CALCIUM
Active Ingredient Strength333 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0093-5352-86

180 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-5352-86)
Marketing Start Date2016-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-5352-86 [00093535286]

Acamprosate Calcium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA200143
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-25

Drug Details

Active Ingredients

IngredientStrength
ACAMPROSATE CALCIUM333 mg/1

OpenFDA Data

SPL SET ID:ca42a543-ae51-4386-9344-0c2d8e7da6f5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835726
  • NDC Crossover Matching brand name "Acamprosate Calcium" or generic name "Acamprosate Calcium"

    NDCBrand NameGeneric Name
    0093-5352Acamprosate CalciumAcamprosate Calcium
    0378-6333Acamprosate Calciumacamprosate calcium enteric-coated
    0904-7213Acamprosate CalciumAcamprosate Calcium
    10135-636Acamprosate CalciumAcamprosate Calcium
    42291-104Acamprosate CalciumAcamprosate Calcium
    51079-241Acamprosate Calciumacamprosate calcium enteric-coated
    60687-121Acamprosate CalciumAcamprosate Calcium
    68382-569acamprosate calciumacamprosate calcium
    68462-435Acamprosate CalciumAcamprosate Calcium
    70771-1057acamprosate calciumacamprosate calcium
    68151-4760Campralacamprosate calcium

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