🇺🇸
United States · US · US:0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a
SIMBRINZA
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100654147251 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER
- ndc1100654147271 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
N204251
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": {
"a49c157e-6310-0011-7b7f-e26fc1820d59": {
"match": "brand_token",
"title": "SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]",
"spl_version": "19",
"published_date": "2025-03-17"
}
},
"productid": "0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a",
"productndc": "0065-4147",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "204251",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.2%;1%",
"product_no": "001",
"approval_date": "Apr 19, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRIMONIDINE TARTRATE; BRINZOLAMIDE",
"proprietary_name": "SIMBRINZA",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA204251",
"marketing_category": "NDA",
"nonproprietary_name": "brinzolamide/brimonidine tartrate",
"start_marketing_date": "20130506",
"active_numerator_strength": "2; 10"
}Related drugs
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