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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
- ndc1170771105701000 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-0)
- ndc117077110571100 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-1)
- ndc11707711057330 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-3)
- ndc117077110575500 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-5)
- ndc117077110578180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1057-8)
- ndc11707711057990 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
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Access this data programmatically
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