🇺🇸
United States · US · US:72888-118_473cb6cb-6b57-127c-e063-6394a90adbe8
CEVIMELINE HYDROCHLORIDE
Orange BookUNIISPLATC N07AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvagen Pharma Ltd
CountryUS (United States)
ATC codeN07AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1172888118001000 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-00)
- ndc117288811801100 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-01)
- ndc117288811805500 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-05)
- ndc11728881183030 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-30)
Annotations
UNII (FDA Substance ID)
P81Q6V85NP
CEVIMELINE HYDROCHLORIDE
RxCUI 260036
Orange Book
A216682
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": "72888-118_473cb6cb-6b57-127c-e063-6394a90adbe8",
"productndc": "72888-118",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "216682",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Apr 6, 2023"
}
],
"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": "ANDA216682",
"marketing_category": "ANDA",
"nonproprietary_name": "CEVIMELINE HYDROCHLORIDE",
"start_marketing_date": "20230406",
"active_numerator_strength": "30"
}Related drugs
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Access this data programmatically
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