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United States · US · US:68382-569_2e5f04a0-3e2d-494f-837b-18570b6a8546

acamprosate calcium

Orange BookUNIISPLATC N07BB03

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

Identification

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

Packs · 6

  • ndc11
    6838256901
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01)
  • ndc11
    6838256905
    500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05)
  • ndc11
    6838256906
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-06)
  • ndc11
    6838256910
    1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-10)
  • ndc11
    6838256916
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-16)
  • ndc11
    6838256928
    180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-28)

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": "68382-569_2e5f04a0-3e2d-494f-837b-18570b6a8546",
  "productndc": "68382-569",
  "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

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