🇺🇸
United States · US · US:60505-0589_afc08ce8-3d89-644d-abdc-61a96ad5d107
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1160505058911 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER
- ndc1160505058921 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER
- ndc1160505058931 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A091442
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": "60505-0589_afc08ce8-3d89-644d-abdc-61a96ad5d107",
"productndc": "60505-0589",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "091442",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2%;EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Apr 20, 2022"
}
],
"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": "ANDA091442",
"marketing_category": "ANDA",
"nonproprietary_name": "Brimonidine Tartrate and Timolol Maleate",
"start_marketing_date": "20221019",
"active_numerator_strength": "2; 5"
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