acamprosate calcium

Generic: acamprosate calcium

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acamprosate calcium
Generic Name acamprosate calcium
Labeler major pharmaceuticals
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

acamprosate calcium 333 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7213
Product ID 0904-7213_70a2162f-c686-46f6-9fe2-6c2e4f36fc21
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 09047213
Hyphenated Format 0904-7213

Supplemental Identifiers

RxCUI
835726
UNII
59375N1D0U

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
  • 30 BLISTER PACK in 1 CARTON (0904-7213-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7213-04 30 BLISTER PACK in 1 CARTON (0904-7213-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

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": "70a2162f-c686-46f6-9fe2-6c2e4f36fc21", "openfda": {"unii": ["59375N1D0U"], "rxcui": ["835726"], "spl_set_id": ["ae6e79c0-a307-4888-b647-1b7be4cb9127"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7213-04)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7213-04", "marketing_start_date": "20130716"}], "brand_name": "Acamprosate Calcium", "product_id": "0904-7213_70a2162f-c686-46f6-9fe2-6c2e4f36fc21", "dosage_form": "TABLET, DELAYED RELEASE", "product_ndc": "0904-7213", "generic_name": "Acamprosate Calcium", "labeler_name": "Major Pharmaceuticals", "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"}