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United States · US · US:65162-890_270f118a-97b1-420b-8504-bfc600008903
Olopatadine Hydrochloride
Orange BookUNIISPLATC R01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeR01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165162890231 BOTTLE, SPRAY in 1 CARTON (65162-890-23) / 665 SPRAY, METERED in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A210901
AB
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": "NASAL",
"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": "65162-890_270f118a-97b1-420b-8504-bfc600008903",
"productndc": "65162-890",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "210901",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.665MG/SPRAY",
"product_no": "001",
"approval_date": "Jan 28, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLOPATADINE HYDROCHLORIDE",
"proprietary_name": "Olopatadine Hydrochloride",
"active_ingred_unit": "ug/1",
"application_number": "ANDA210901",
"marketing_category": "ANDA",
"nonproprietary_name": "Olopatadine Hydrochloride",
"start_marketing_date": "20200203",
"active_numerator_strength": "665"
}Related drugs
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