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United States · US · US:46122-823_ea97d3d8-dc96-4c40-91e7-f076c588bf12
OLOPATADINE HYDROCHLORIDE
Orange BookUNIISPLATC R01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerisourceBergen Drug Corp
CountryUS (United States)
ATC codeR01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1146122823291 BOTTLE, PLASTIC in 1 CARTON (46122-823-29) / 5 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A200810
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": "46122-823_ea97d3d8-dc96-4c40-91e7-f076c588bf12",
"productndc": "46122-823",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "200810",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.1% BASE",
"product_no": "001",
"approval_date": "Jun 28, 2017"
}
],
"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": "ANDA200810",
"marketing_category": "ANDA",
"nonproprietary_name": "Olopatadine Hydrochloride ophthalmic",
"start_marketing_date": "20260501",
"active_numerator_strength": "1"
}Related drugs
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