acamprosate calcium

Generic: acamprosate calcium

Labeler: bionpharma inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acamprosate calcium
Generic Name acamprosate calcium
Labeler bionpharma inc.,
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

acamprosate calcium 333 mg/1

Manufacturer
Bionpharma Inc.,

Identifiers & Regulatory

Product NDC 69452-353
Product ID 69452-353_44732224-b730-9a24-e063-6394a90ac0c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219904
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452353
Hyphenated Format 69452-353

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 ANDA219904 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 333 mg/1
source: ndc
Packaging
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25)
source: ndc

Packages (1)

69452-353-25 180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25)

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": "44732224-b730-9a24-e063-6394a90ac0c0", "openfda": {"unii": ["59375N1D0U"], "rxcui": ["835726"], "spl_set_id": ["4473326f-79f1-61b2-e063-6294a90a17a3"], "manufacturer_name": ["Bionpharma Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25)", "package_ndc": "69452-353-25", "marketing_start_date": "20251201"}], "brand_name": "Acamprosate Calcium", "product_id": "69452-353_44732224-b730-9a24-e063-6394a90ac0c0", "dosage_form": "TABLET, DELAYED RELEASE", "product_ndc": "69452-353", "generic_name": "Acamprosate Calcium", "labeler_name": "Bionpharma Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acamprosate Calcium", "active_ingredients": [{"name": "ACAMPROSATE CALCIUM", "strength": "333 mg/1"}], "application_number": "ANDA219904", "marketing_category": "ANDA", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}