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United States · US · US:69315-325_b6fecc68-5e40-4191-a365-568ccedf0697
TIMOLOL MALEATE
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1169315325055 mL in 1 BOTTLE, PLASTIC (69315-325-05)
- ndc11693153251010 mL in 1 BOTTLE, PLASTIC (69315-325-10)
- ndc11693153251515 mL in 1 BOTTLE, PLASTIC (69315-325-15)
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A218460
AT1
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": "69315-325_b6fecc68-5e40-4191-a365-568ccedf0697",
"productndc": "69315-325",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "218460",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Aug 7, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "TIMOLOL MALEATE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218460",
"marketing_category": "ANDA",
"nonproprietary_name": "TIMOLOL MALEATE",
"start_marketing_date": "20241107",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA06.
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