🇺🇸
United States · US · US:70000-0716_32c153a7-d51f-72c5-e063-6294a90aee29
LEADER OLOPATADINE HYDROCHLORIDE
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
- ndc1170000071611 BOTTLE, PLASTIC in 1 CARTON (70000-0716-1) / 3.5 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A206087
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": "70000-0716_32c153a7-d51f-72c5-e063-6294a90aee29",
"productndc": "70000-0716",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "206087",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.2% BASE",
"product_no": "001",
"approval_date": "Dec 5, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "OLOPATADINE HYDROCHLORIDE",
"proprietary_name": "LEADER OLOPATADINE HYDROCHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206087",
"marketing_category": "ANDA",
"nonproprietary_name": "OLOPATADINE HYDROCHLORIDE",
"start_marketing_date": "20250415",
"active_numerator_strength": "2"
}Related drugs
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Access this data programmatically
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