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United States · US · US:68083-564_fac898b8-b3e7-4db5-a3ff-a3ebcdca84cf
Latanoprostene Bunod Ophthalmic Solution, 0.024%
Orange BookUNIISPLATC S01EE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeS01EE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083564011 BOTTLE in 1 CARTON (68083-564-01) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
I6393O0922
LATANOPROSTENE BUNOD
RxCUI 1988390
Orange Book
A217387
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "I6393O0922",
"rxcui": "1988390",
"inchikey": "LOVMMUBRQUFEAH-UIEAZXIASA-N",
"display_name": "LATANOPROSTENE BUNOD",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"1beedfbd-5e2b-4ab1-ab8e-8320e69af1ea": {
"match": "brand_token",
"title": "LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION, 0.024% SOLUTION/ DROPS [GLAND PHARMA LIMITED]",
"spl_version": "6",
"published_date": "2025-05-05"
}
},
"productid": "68083-564_fac898b8-b3e7-4db5-a3ff-a3ebcdca84cf",
"productndc": "68083-564",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "217387",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.024%",
"product_no": "001",
"approval_date": "Apr 29, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LATANOPROSTENE BUNOD",
"proprietary_name": "Latanoprostene Bunod Ophthalmic Solution, 0.024%",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217387",
"marketing_category": "ANDA",
"nonproprietary_name": "Latanoprostene Bunod Ophthalmic Solution, 0.024%",
"start_marketing_date": "20250429",
"active_numerator_strength": ".24"
}Related drugs
Other records sharing ATC code S01EE06.
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