🇺🇸
United States · US · US:69315-330_16b451fa-d16e-4138-a5b9-e4424e56920b
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1169315330051 BOTTLE, DROPPER in 1 CARTON (69315-330-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1169315330101 BOTTLE, DROPPER in 1 CARTON (69315-330-10) / 10 mL in 1 BOTTLE, DROPPER
- ndc1169315330151 BOTTLE, DROPPER in 1 CARTON (69315-330-15) / 15 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A219093
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4S9CL2DY2H",
"rxcui": "39171",
"inchikey": "QZHBYNSSDLTCRG-LREBCSMRSA-N",
"display_name": "BRIMONIDINE TARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"f6666d85-f810-4869-993d-e8ae35b4517f": {
"match": "brand_token",
"title": "BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION SOLUTION/ DROPS [LIFESTAR PHARMA LLC]",
"spl_version": "5",
"published_date": "2026-06-02"
}
},
"productid": "69315-330_16b451fa-d16e-4138-a5b9-e4424e56920b",
"productndc": "69315-330",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "219093",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2%;EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Feb 25, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
"proprietary_name": "Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA219093",
"marketing_category": "ANDA",
"nonproprietary_name": "Brimonidine Tartrate and Timolol Maleate",
"start_marketing_date": "20250529",
"active_numerator_strength": "2; 5"
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