🇺🇸
United States · US · US:46708-706_b5d560b6-847e-4f09-b1ef-22e4deb8a206
Brimonidine Tartrate and Timolol Maleate
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1146708706051 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1146708706101 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER
- ndc1146708706151 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A215230
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": "46708-706_b5d560b6-847e-4f09-b1ef-22e4deb8a206",
"productndc": "46708-706",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "215230",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2%;EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Aug 25, 2023"
}
],
"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": "ANDA215230",
"marketing_category": "ANDA",
"nonproprietary_name": "Brimonidine Tartrate and Timolol Maleate",
"start_marketing_date": "20230825",
"active_numerator_strength": "2; 5"
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