acamprosate calcium

Generic: acamprosate calcium

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acamprosate calcium
Generic Name acamprosate calcium
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

acamprosate calcium 333 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-569
Product ID 68382-569_2e5f04a0-3e2d-494f-837b-18570b6a8546
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205995
Listing Expiration 2026-12-31
Marketing Start 2017-06-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382569
Hyphenated Format 68382-569

Supplemental Identifiers

RxCUI
835726
UNII
59375N1D0U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acamprosate calcium (source: ndc)
Generic Name acamprosate calcium (source: ndc)
Application Number ANDA205995 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 333 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-06)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-10)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-16)
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-28)
source: ndc

Packages (6)

68382-569-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01) 68382-569-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05) 68382-569-06 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-06) 68382-569-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-10) 68382-569-16 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-16) 68382-569-28 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-28)

Ingredients (1)

acamprosate calcium (333 mg/1)

Linked Drug Pages (1)

acamprosate calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2e5f04a0-3e2d-494f-837b-18570b6a8546", "openfda": {"unii": ["59375N1D0U"], "rxcui": ["835726"], "spl_set_id": ["9803db35-2600-4f42-80c1-43216fd1ba3d"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01)", "package_ndc": "68382-569-01", "marketing_start_date": "20170601"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05)", "package_ndc": "68382-569-05", "marketing_start_date": "20170601"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-06)", "package_ndc": "68382-569-06", "marketing_start_date": "20170601"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-10)", "package_ndc": "68382-569-10", "marketing_start_date": "20170601"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-16)", "package_ndc": "68382-569-16", "marketing_start_date": "20170601"}, {"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-28)", "package_ndc": "68382-569-28", "marketing_start_date": "20170601"}], "brand_name": "acamprosate calcium", "product_id": "68382-569_2e5f04a0-3e2d-494f-837b-18570b6a8546", "dosage_form": "TABLET, DELAYED RELEASE", "product_ndc": "68382-569", "generic_name": "acamprosate calcium", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "acamprosate calcium", "active_ingredients": [{"name": "ACAMPROSATE CALCIUM", "strength": "333 mg/1"}], "application_number": "ANDA205995", "marketing_category": "ANDA", "marketing_start_date": "20170601", "listing_expiration_date": "20261231"}