Acamprosate Calcium

Orange BookUNIISPLATC N07BB03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN07BB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378633380
180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)

Annotations

UNII (FDA Substance ID)

59375N1D0U

ACAMPROSATE CALCIUM

RxCUI 152761

Orange Book

A200142

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "59375N1D0U",
    "rxcui": "152761",
    "inchikey": "BUVGWDNTAWHSKI-UHFFFAOYSA-L",
    "display_name": "ACAMPROSATE CALCIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "91769a96-3182-4e38-90c3-b22c1beae398": {
      "match": "brand_token",
      "title": "ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]",
      "spl_version": "1",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0378-6333_e06868f1-f40b-4762-bd52-53a5ba825619",
  "productndc": "0378-6333",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "200142",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "333MG",
        "product_no": "001",
        "approval_date": "Mar 11, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACAMPROSATE CALCIUM",
  "proprietary_name": "Acamprosate Calcium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA200142",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acamprosate calcium enteric-coated",
  "start_marketing_date": "20140924",
  "active_numerator_strength": "333"
}

Related drugs

Other records sharing ATC code N07BB03.

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