🇺🇸
United States · US · US:0832-1425_26693226-0059-2890-e063-6394a90abf9a
Brimonidine Tartrate and Timolol Maleate
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1108321425051 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1108321425101 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER
- ndc1108321425151 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A215598
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": "0832-1425_26693226-0059-2890-e063-6394a90abf9a",
"productndc": "0832-1425",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "215598",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2%;EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Dec 12, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
"proprietary_name": "Brimonidine Tartrate and Timolol Maleate",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA215598",
"marketing_category": "ANDA",
"nonproprietary_name": "Brimonidine Tartrate and Timolol Maleate",
"start_marketing_date": "20221215",
"active_numerator_strength": "2; 5"
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