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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
- ndc116838256901100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01)
- ndc116838256905500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05)
- ndc11683825690630 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-06)
- ndc1168382569101000 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-10)
- ndc11683825691690 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-16)
- ndc116838256928180 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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