acamprosate calcium

Generic: acamprosate calcium enteric-coated

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acamprosate calcium
Generic Name acamprosate calcium enteric-coated
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

acamprosate calcium 333 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6333
Product ID 0378-6333_e06868f1-f40b-4762-bd52-53a5ba825619
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200142
Listing Expiration 2026-12-31
Marketing Start 2014-09-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786333
Hyphenated Format 0378-6333

Supplemental Identifiers

RxCUI
835726
UPC
0303786333806
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 enteric-coated (source: ndc)
Application Number ANDA200142 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 333 mg/1
source: ndc
Packaging
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)
source: ndc

Packages (1)

0378-6333-80 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)

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": "e06868f1-f40b-4762-bd52-53a5ba825619", "openfda": {"upc": ["0303786333806"], "unii": ["59375N1D0U"], "rxcui": ["835726"], "spl_set_id": ["75ddfd10-55b2-426e-bc74-3413cd0d7c94"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)", "package_ndc": "0378-6333-80", "marketing_start_date": "20140924"}], "brand_name": "Acamprosate Calcium", "product_id": "0378-6333_e06868f1-f40b-4762-bd52-53a5ba825619", "dosage_form": "TABLET, DELAYED RELEASE", "product_ndc": "0378-6333", "generic_name": "acamprosate calcium enteric-coated", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acamprosate Calcium", "active_ingredients": [{"name": "ACAMPROSATE CALCIUM", "strength": "333 mg/1"}], "application_number": "ANDA200142", "marketing_category": "ANDA", "marketing_start_date": "20140924", "listing_expiration_date": "20261231"}