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United States · US · US:70069-516_71408752-090e-4566-9cdf-7e0074200d3a
Timolol hemihydrate
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170069516011 BOTTLE in 1 CARTON (70069-516-01) / 2.5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A216653
AT2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P8Y54F701R",
"rxcui": "42933",
"inchikey": "WLRMANUAADYWEA-NWASOUNVSA-N",
"display_name": "TIMOLOL MALEATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"e16c33fd-aa86-49ad-a767-c79ade4a62c7": {
"match": "brand_token",
"title": "TIMOLOL MALEATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]",
"spl_version": "16",
"published_date": "2026-05-25"
}
},
"productid": "70069-516_71408752-090e-4566-9cdf-7e0074200d3a",
"productndc": "70069-516",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "216653",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT2",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Jul 3, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "Timolol hemihydrate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216653",
"marketing_category": "ANDA",
"nonproprietary_name": "Timolol hemihydrate",
"start_marketing_date": "20240709",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA06.
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