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United States · US · US:82584-010_4badbaf4-122e-3878-e063-6294a90ab4ba
ZOLYMBUS
Orange BookUNIISPLATC S01EE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerThea Pharma Inc.
CountryUS (United States)
ATC codeS01EE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1182584010101 POUCH in 1 CARTON (82584-010-10) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSE
- ndc1182584010303 POUCH in 1 CARTON (82584-010-30) / 10 VIAL, SINGLE-DOSE in 1 POUCH (82584-010-81) / .3 g in 1 VIAL, SINGLE-DOSE
- ndc1182584010353 POUCH in 1 CARTON (82584-010-35) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
QXS94885MZ
BIMATOPROST
RxCUI 283810
Orange Book
N217307
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QXS94885MZ",
"rxcui": "283810",
"inchikey": "AQOKCDNYWBIDND-FTOWTWDKSA-N",
"display_name": "BIMATOPROST",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"f4504a0c-7998-4084-9e05-f999f1d051ed": {
"match": "brand_token",
"title": "ZOLYMBUS (BIMATOPROST) GEL [THEA PHARMA INC.]",
"spl_version": "5",
"published_date": "2026-02-27"
}
},
"productid": "82584-010_4badbaf4-122e-3878-e063-6294a90ab4ba",
"productndc": "82584-010",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "217307",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.01%",
"product_no": "001",
"approval_date": "Sep 9, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIMATOPROST",
"proprietary_name": "ZOLYMBUS",
"active_ingred_unit": "mg/g",
"application_number": "NDA217307",
"marketing_category": "NDA",
"nonproprietary_name": "bimatoprost",
"start_marketing_date": "20260226",
"active_numerator_strength": ".1"
}Related drugs
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