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United States · US · US:45802-078_6d6fa6f0-e1c6-4ea1-a4fb-8ad511a95d75
BRIMONIDINE
Orange BookUNIISPLATC S01GA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeS01GA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1145802078301 BOTTLE, PUMP in 1 CARTON (45802-078-30) / 30 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A209158
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": "TOPICAL",
"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": "45802-078_6d6fa6f0-e1c6-4ea1-a4fb-8ad511a95d75",
"productndc": "45802-078",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "209158",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.33% BASE",
"product_no": "001",
"approval_date": "Sep 23, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRIMONIDINE TARTRATE",
"proprietary_name": "BRIMONIDINE",
"active_ingred_unit": "mg/g",
"application_number": "ANDA209158",
"marketing_category": "ANDA",
"nonproprietary_name": "brimonidine",
"start_marketing_date": "20230101",
"active_numerator_strength": "5"
}Related drugs
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