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United States · US · US:42571-403_238fd036-1868-da83-e063-6394a90a0596
Timolol Maleate
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1142571403215 mL in 1 BOTTLE (42571-403-21)
- ndc11425714038810 mL in 1 BOTTLE (42571-403-88)
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A217343
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": "42571-403_238fd036-1868-da83-e063-6394a90a0596",
"productndc": "42571-403",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "217343",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 0.25% BASE",
"product_no": "001",
"approval_date": "May 26, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 0.5% BASE",
"product_no": "002",
"approval_date": "May 26, 2023"
}
],
"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": "ANDA217343",
"marketing_category": "ANDA",
"nonproprietary_name": "Timolol Maleate Ophthalmic",
"start_marketing_date": "20230801",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code C07AA06.
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