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United States · US · US:87047-7852_453d0158-979d-12a6-e063-6294a90afe7f
CYKLX
Orange BookUNIISPLATC N01BB58
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Genomics, LLC
CountryUS (United States)
ATC codeN01BB58
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11870477852110 POUCH in 1 CARTON (87047-7852-1) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE
- ndc1187047785222 POUCH in 1 CARTON (87047-7852-2) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
QS9014Q792
ARTICAINE HYDROCHLORIDE
RxCUI 2117
Orange Book
N218643
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QS9014Q792",
"rxcui": "2117",
"inchikey": "GDWDBGSWGNEMGJ-UHFFFAOYSA-N",
"display_name": "ARTICAINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"60e89ad4-8b65-4049-82ba-f34d4836eac0": {
"match": "brand_token",
"title": "CYKLX (ARTICAINE HYDROCHLORIDE) SOLUTION/ DROPS [AMERICAN GENOMICS, LLC]",
"spl_version": "4",
"published_date": "2026-04-02"
}
},
"productid": "87047-7852_453d0158-979d-12a6-e063-6294a90afe7f",
"productndc": "87047-7852",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "218643",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 8% BASE",
"product_no": "001",
"approval_date": "Aug 15, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARTICAINE HYDROCHLORIDE",
"proprietary_name": "CYKLX",
"active_ingred_unit": "mg/mL",
"application_number": "NDA218643",
"marketing_category": "NDA",
"nonproprietary_name": "articaine hydrochloride",
"start_marketing_date": "20260402",
"active_numerator_strength": "80"
}Related drugs
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