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United States · US · US:0054-0334_3cca3720-dca8-40cf-8de7-8f3444125ece
Cevimeline Hydrochloride
Orange BookUNIISPLATC N07AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN07AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054033425100 CAPSULE in 1 BOTTLE (0054-0334-25)
Annotations
UNII (FDA Substance ID)
P81Q6V85NP
CEVIMELINE HYDROCHLORIDE
RxCUI 260036
Orange Book
A091591
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": "0054-0334_3cca3720-dca8-40cf-8de7-8f3444125ece",
"productndc": "0054-0334",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "091591",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Jul 8, 2013"
}
],
"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": "ANDA091591",
"marketing_category": "ANDA",
"nonproprietary_name": "Cevimeline Hydrochloride",
"start_marketing_date": "20130708",
"active_numerator_strength": "30"
}Related drugs
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