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United States · US · US:72789-457_48d8a76e-8103-9485-e063-6294a90af9ab
CEVIMELINE HYDROCHLORIDE
Orange BookUNIISPLATC N07AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN07AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117278945701100 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-01)
- ndc11727894573030 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-30)
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": "72789-457_48d8a76e-8103-9485-e063-6294a90af9ab",
"productndc": "72789-457",
"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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