acamprosate calcium

Generic: acamprosate calcium

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

acamprosate calcium 333 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-435
Product ID 68462-435_6560e0ea-e882-4fcd-b523-8c5474d32f91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202229
Listing Expiration 2027-12-31
Marketing Start 2013-07-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462435
Hyphenated Format 68462-435

Supplemental Identifiers

RxCUI
835726
UPC
0368462435182
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 ANDA202229 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 333 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (68462-435-11) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68462-435-18)
source: ndc

Packages (2)

68462-435-11 10 BLISTER PACK in 1 CARTON (68462-435-11) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK 68462-435-18 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68462-435-18)

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": "6560e0ea-e882-4fcd-b523-8c5474d32f91", "openfda": {"upc": ["0368462435182"], "unii": ["59375N1D0U"], "rxcui": ["835726"], "spl_set_id": ["43e9ef60-2d85-4394-906b-93042fea099a"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-435-11)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "68462-435-11", "marketing_start_date": "20130716"}, {"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (68462-435-18)", "package_ndc": "68462-435-18", "marketing_start_date": "20130716"}], "brand_name": "Acamprosate Calcium", "product_id": "68462-435_6560e0ea-e882-4fcd-b523-8c5474d32f91", "dosage_form": "TABLET, DELAYED RELEASE", "product_ndc": "68462-435", "generic_name": "Acamprosate Calcium", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acamprosate Calcium", "active_ingredients": [{"name": "ACAMPROSATE CALCIUM", "strength": "333 mg/1"}], "application_number": "ANDA202229", "marketing_category": "ANDA", "marketing_start_date": "20130716", "listing_expiration_date": "20271231"}