🇺🇸
United States · US · US:70000-0717_32bff197-0006-d853-e063-6394a90a8cc2
Leader Olopatadine Hydrochloride Ophthalmic Solution
Orange BookUNIISPLATC R01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCARDINAL HEALTH
CountryUS (United States)
ATC codeR01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170000071711 BOTTLE in 1 CARTON (70000-0717-1) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A206046
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2XG66W44KF",
"rxcui": "236599",
"inchikey": "HVRLZEKDTUEKQH-NOILCQHBSA-N",
"display_name": "OLOPATADINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"12971fb2-2314-4443-bf70-b7eb5859b148": {
"match": "brand_token",
"title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "70000-0717_32bff197-0006-d853-e063-6394a90a8cc2",
"productndc": "70000-0717",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "206046",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.1% BASE",
"product_no": "001",
"approval_date": "Jul 26, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "OLOPATADINE HYDROCHLORIDE",
"proprietary_name": "Leader Olopatadine Hydrochloride Ophthalmic Solution",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206046",
"marketing_category": "ANDA",
"nonproprietary_name": "Olopatadine Hydrochloride Ophthalmic Solution",
"start_marketing_date": "20250415",
"active_numerator_strength": "1"
}Related drugs
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Access this data programmatically
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