🇺🇸
United States · US · US:24208-966_258be954-8e76-2be4-e063-6394a90a78ca
Olopatadine Hydrochloride Ophthalmic Solution
Orange BookUNIISPLATC R01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeR01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1124208966011 BOTTLE in 1 CARTON (24208-966-01) / 5 mL in 1 BOTTLE
- ndc1124208966022 BOTTLE in 1 CARTON (24208-966-02) / 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": {
"96ad3623-f7cc-4c1c-aa65-d89077873b69": {
"match": "brand_token",
"title": "OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [RUGBY LABORATORIES]",
"spl_version": "4",
"published_date": "2026-05-22"
}
},
"productid": "24208-966_258be954-8e76-2be4-e063-6394a90a78ca",
"productndc": "24208-966",
"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": "Olopatadine Hydrochloride Ophthalmic Solution",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206046",
"marketing_category": "ANDA",
"nonproprietary_name": "Olopatadine Hydrochloride Ophthalmic Solution",
"start_marketing_date": "20241202",
"active_numerator_strength": "1"
}Related drugs
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