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United States · US · US:82260-813_2f8c4356-d1fe-ff3f-e063-6394a90a2832
Timolol Maleate
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch & Lomb Americas Inc.
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182260813051 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING
- ndc1182260813101 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
N018086
AT1AT1
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": "82260-813_2f8c4356-d1fe-ff3f-e063-6394a90a2832",
"productndc": "82260-813",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "018086",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AT1",
"strength": "EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AT1",
"strength": "EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "Timolol Maleate",
"active_ingred_unit": "mg/mL",
"application_number": "NDA018086",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Timolol Maleate",
"start_marketing_date": "20200601",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA06.
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