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United States · US · US:0591-5321_dc55f802-2977-4761-b1c5-179c1bd7a336
Primidone
Orange BookUNIISPLATC N03AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN03AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110591532101100 TABLET in 1 BOTTLE, PLASTIC (0591-5321-01)
Annotations
UNII (FDA Substance ID)
13AFD7670Q
PRIMIDONE
RxCUI 8691
Orange Book
A083551
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "13AFD7670Q",
"rxcui": "8691",
"inchikey": "DQMZLTXERSFNPB-UHFFFAOYSA-N",
"display_name": "PRIMIDONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e7a50a67-9653-463e-8c85-315b53f460c8": {
"match": "brand_token",
"title": "PRIMIDONE TABLET [AVKARE]",
"spl_version": "11",
"published_date": "2026-05-15"
}
},
"productid": "0591-5321_dc55f802-2977-4761-b1c5-179c1bd7a336",
"productndc": "0591-5321",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "083551",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRIMIDONE",
"proprietary_name": "Primidone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA083551",
"marketing_category": "ANDA",
"nonproprietary_name": "Primidone",
"start_marketing_date": "20100619",
"active_numerator_strength": "250"
}Related drugs
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- GBLiskantin Saft 125mg/5ml oral suspensionImported (Germany)
- PLMizodinZakłady Farmaceutyczne "UNIA" Spółdzielnia Pracy
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