🇺🇸
United States · US · US:43598-764_bdf7e94a-e260-6ba4-3545-aac867c9dade
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
- ndc1143598764021 BOTTLE, PLASTIC in 1 CARTON (43598-764-02) / 2.5 mL in 1 BOTTLE, PLASTIC
- ndc1143598764252 BOTTLE, PLASTIC in 1 CARTON (43598-764-25) / 2.5 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A209752
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": "43598-764_bdf7e94a-e260-6ba4-3545-aac867c9dade",
"productndc": "43598-764",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "209752",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.2% BASE",
"product_no": "001",
"approval_date": "May 20, 2020"
}
],
"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": "ANDA209752",
"marketing_category": "ANDA",
"nonproprietary_name": "Olopatadine Hydrochloride Ophthalmic",
"start_marketing_date": "20200901",
"active_numerator_strength": "2"
}Related drugs
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