🇺🇸
United States · US · US:40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10ba
cevimeline hydrochloride
Orange BookUNIISPLATC N07AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovel Laboratories, Inc.
CountryUS (United States)
ATC codeN07AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114003299901100 CAPSULE in 1 BOTTLE (40032-999-01)
- ndc11400329990330 CAPSULE in 1 BOTTLE (40032-999-03)
- ndc114003299905500 CAPSULE in 1 BOTTLE (40032-999-05)
Annotations
UNII (FDA Substance ID)
P81Q6V85NP
CEVIMELINE HYDROCHLORIDE
RxCUI 260036
Orange Book
A204746
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": "40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10ba",
"productndc": "40032-999",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204746",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Dec 30, 2016"
}
],
"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": "ANDA204746",
"marketing_category": "ANDA",
"nonproprietary_name": "cevimeline hydrochloride",
"start_marketing_date": "20161230",
"active_numerator_strength": "30"
}Related drugs
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