NDC 70771-1057

acamprosate calcium

Acamprosate Calcium

acamprosate calcium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Acamprosate Calcium.

Product ID70771-1057_4c70c0ac-fbca-4d17-9cf1-01ad6a7a3f25
NDC70771-1057
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 NameCadila Healthcare Limited
Substance NameACAMPROSATE CALCIUM
Active Ingredient Strength333 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70771-1057-0

1000 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-0)
Marketing Start Date2017-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1057-1 [70771105701]

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

NDC 70771-1057-5 [70771105705]

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

NDC 70771-1057-3 [70771105703]

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

NDC 70771-1057-9 [70771105709]

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

NDC 70771-1057-0 [70771105700]

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

NDC 70771-1057-8 [70771105708]

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

Drug Details

Active Ingredients

IngredientStrength
ACAMPROSATE CALCIUM333 mg/1

OpenFDA Data

SPL SET ID:0c729939-d2d2-4e61-acbc-4f1646dc38c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835726
    • UPC Code
  • 0370771105786

    • 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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