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United States · US · US:69452-353_44732224-b730-9a24-e063-6394a90ac0c0

Acamprosate Calcium

Orange BookUNIISPLATC N07BB03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBionpharma Inc.,
CountryUS (United States)
ATC codeN07BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6945235325
    180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25)

Annotations

UNII (FDA Substance ID)
59375N1D0U
ACAMPROSATE CALCIUM
RxCUI 152761
Orange Book
A219904
AB
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": "69452-353_44732224-b730-9a24-e063-6394a90ac0c0",
  "productndc": "69452-353",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "219904",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "333MG",
        "product_no": "001",
        "approval_date": "Sep 18, 2025"
      }
    ],
    "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": "ANDA219904",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acamprosate Calcium",
  "start_marketing_date": "20251201",
  "active_numerator_strength": "333"
}

Related drugs

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