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United States · US · US:72578-208_4518aba1-9402-4137-a7f0-6b24ec60efda
Cevimeline Hydrochloride
Orange BookUNIISPLATC N07AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeN07AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117257820801100 CAPSULE in 1 BOTTLE (72578-208-01)
Annotations
UNII (FDA Substance ID)
P81Q6V85NP
CEVIMELINE HYDROCHLORIDE
RxCUI 260036
Orange Book
A220267
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P81Q6V85NP",
"rxcui": "260036",
"inchikey": "ZSTLCHCDLIUXJE-ZGBAEQJLSA-N;ZSTLCHCDLIUXJE-GMLJRNIPSA-N",
"display_name": "CEVIMELINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"bcaaec18-4ee1-4cfd-84da-8fe3b8c54fc4": {
"match": "brand_token",
"title": "CEVIMELINE HYDROCHLORIDE CAPSULE [ASCLEMED USA INC.]",
"spl_version": "1",
"published_date": "2026-05-21"
}
},
"productid": "72578-208_4518aba1-9402-4137-a7f0-6b24ec60efda",
"productndc": "72578-208",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "220267",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Mar 11, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEVIMELINE HYDROCHLORIDE",
"proprietary_name": "Cevimeline Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA220267",
"marketing_category": "ANDA",
"nonproprietary_name": "Cevimeline Hydrochloride",
"start_marketing_date": "20260415",
"active_numerator_strength": "30"
}Related drugs
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