🇺🇸
United States · US · US:75907-285_32d8bd94-1b82-6ec2-53ad-9de2c4c26ea5
Olopatadine Hydrochloride Ophthalmic Solution
Orange BookUNIISPLATC R01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeR01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1175907285021 BOTTLE, DROPPER in 1 CARTON (75907-285-02) / 2.5 mL in 1 BOTTLE, DROPPER
- ndc1175907285252 BOTTLE, DROPPER in 1 CARTON (75907-285-25) / 2.5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A213514
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": "75907-285_32d8bd94-1b82-6ec2-53ad-9de2c4c26ea5",
"productndc": "75907-285",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "213514",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.7% BASE",
"product_no": "001",
"approval_date": "Jan 6, 2026"
}
],
"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": "ANDA213514",
"marketing_category": "ANDA",
"nonproprietary_name": "olopatadine hydrochloride",
"start_marketing_date": "20260415",
"active_numerator_strength": "7"
}Related drugs
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