🇺🇸
United States · US · US:70069-008_a873a505-bb9c-4430-8921-8d800df991c7
EPINASTINE HYDROCHLORIDE
Orange BookUNIISPLATC S01GX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeS01GX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170069008011 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
GFM415S5XL
EPINASTINE HYDROCHLORIDE
RxCUI 236961
Orange Book
A090951
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "GFM415S5XL",
"rxcui": "236961",
"inchikey": "VKXSGUIOOQPGAF-UHFFFAOYSA-N",
"display_name": "EPINASTINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"0d4ee45c-e58f-4b7c-b389-898f5c27f54d": {
"match": "brand_token",
"title": "EPINASTINE HYDROCHLORIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]",
"spl_version": "7",
"published_date": "2025-03-26"
}
},
"productid": "70069-008_a873a505-bb9c-4430-8921-8d800df991c7",
"productndc": "70069-008",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "090951",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "0.05%",
"product_no": "001",
"approval_date": "Oct 31, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPINASTINE HYDROCHLORIDE",
"proprietary_name": "EPINASTINE HYDROCHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA090951",
"marketing_category": "ANDA",
"nonproprietary_name": "EPINASTINE HYDROCHLORIDE",
"start_marketing_date": "20160914",
"active_numerator_strength": ".5"
}Related drugs
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