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United States · US · US:16571-224_ebb620d8-8e2e-4632-b8a8-74f41c9969e6
Timolol Maleate
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc111657122401100 TABLET in 1 BOTTLE (16571-224-01)
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A207556
AB
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": "ORAL",
"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": "16571-224_ebb620d8-8e2e-4632-b8a8-74f41c9969e6",
"productndc": "16571-224",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207556",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "May 2, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "May 2, 2019"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "003",
"approval_date": "May 2, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "Timolol Maleate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207556",
"marketing_category": "ANDA",
"nonproprietary_name": "Timolol Maleate",
"start_marketing_date": "20241210",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C07AA06.
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