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United States · US · US:70771-1057_c9752e78-2bf3-4e62-a947-a3d7fe757a1b

acamprosate calcium

Orange BookUNIISPLATC N07BB03

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN07BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7077110570
    1000 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-0)
  • ndc11
    7077110571
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-1)
  • ndc11
    7077110573
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-3)
  • ndc11
    7077110575
    500 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-5)
  • ndc11
    7077110578
    180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-8)
  • ndc11
    7077110579
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-9)

Annotations

UNII (FDA Substance ID)
59375N1D0U
ACAMPROSATE CALCIUM
RxCUI 152761
Orange Book
A205995
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": "70771-1057_c9752e78-2bf3-4e62-a947-a3d7fe757a1b",
  "productndc": "70771-1057",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "205995",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "333MG",
        "product_no": "001",
        "approval_date": "May 26, 2017"
      }
    ],
    "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": "ANDA205995",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acamprosate calcium",
  "start_marketing_date": "20170601",
  "active_numerator_strength": "333"
}

Related drugs

Other records sharing ATC code N07BB03.

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