🇺🇸
United States · US · US:16571-882_c23fbb1d-8ba4-4375-aedf-f2346dde7746
olopatadine hydrochloride
Orange BookUNIISPLATC R01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeR01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1116571882051 CONTAINER in 1 CARTON (16571-882-05) / 5 mL in 1 CONTAINER
Annotations
UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A204392
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": "16571-882_c23fbb1d-8ba4-4375-aedf-f2346dde7746",
"productndc": "16571-882",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "204392",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.1% BASE",
"product_no": "001",
"approval_date": "Mar 21, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "OLOPATADINE HYDROCHLORIDE",
"proprietary_name": "olopatadine hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA204392",
"marketing_category": "ANDA",
"nonproprietary_name": "olopatadine hydrochloride",
"start_marketing_date": "20250501",
"active_numerator_strength": "1"
}Related drugs
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