🇺🇸
United States · US · US:68462-281_e97c8703-5166-49b6-8dd2-69c5b9dfcae8
Brimonidine Tartrate/Timolol Maleate
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168462281321 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER
- ndc1168462281691 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A214987
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": "68462-281_e97c8703-5166-49b6-8dd2-69c5b9dfcae8",
"productndc": "68462-281",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "214987",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2%;EQ 0.5% BASE",
"product_no": "001",
"approval_date": "May 16, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
"proprietary_name": "Brimonidine Tartrate/Timolol Maleate",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA214987",
"marketing_category": "ANDA",
"nonproprietary_name": "Brimonidine Tartrate and Timolol Maleate",
"start_marketing_date": "20240516",
"active_numerator_strength": "2; 5"
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