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United States · US · US:61314-224_ba538348-67cf-4031-84e5-cb84647af104
Timolol GFS
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1161314224055 mL in 1 BOTTLE (61314-224-05)
- ndc1161314224252.5 mL in 1 BOTTLE (61314-224-25)
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
N020963
ABAB
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": "61314-224_ba538348-67cf-4031-84e5-cb84647af104",
"productndc": "61314-224",
"dosage_form": "SOLUTION, GEL FORMING / DROPS",
"orange_book": {
"appl_no": "020963",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.25% BASE",
"product_no": "001",
"approval_date": "Oct 21, 1998"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.5% BASE",
"product_no": "002",
"approval_date": "Oct 21, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "Timolol GFS",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020963",
"marketing_category": "NDA",
"nonproprietary_name": "timolol maleate",
"start_marketing_date": "19981224",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code C07AA06.
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