NDC 68382-569

acamprosate calcium

Acamprosate Calcium

acamprosate calcium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Acamprosate Calcium.

Product ID68382-569_9435df69-f78d-4336-9f90-99fe4182340c
NDC68382-569
Product TypeHuman Prescription Drug
Proprietary Nameacamprosate calcium
Generic NameAcamprosate Calcium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2017-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA205995
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameACAMPROSATE CALCIUM
Active Ingredient Strength333 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68382-569-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01)
Marketing Start Date2017-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-569-05 [68382056905]

acamprosate calcium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01

NDC 68382-569-10 [68382056910]

acamprosate calcium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01

NDC 68382-569-01 [68382056901]

acamprosate calcium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01

NDC 68382-569-16 [68382056916]

acamprosate calcium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01

NDC 68382-569-06 [68382056906]

acamprosate calcium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205995
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01

NDC 68382-569-28 [68382056928]

acamprosate calcium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205995
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-01

Drug Details

Active Ingredients

IngredientStrength
ACAMPROSATE CALCIUM333 mg/1

OpenFDA Data

SPL SET ID:9803db35-2600-4f42-80c1-43216fd1ba3d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835726
    • UPC Code
  • 0368382569288

    • Medicade Reported Pricing

    68382056928 ACAMPROSATE CALC DR 333 MG TAB

    Pricing Unit: EA | Drug Type:

    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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