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United States · US · US:50742-287_a6586769-4fb8-41df-bfd6-0971090ab79b
Timolol Maleate
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11507422876015 POUCH in 1 CARTON (50742-287-60) / 4 CONTAINER in 1 POUCH (50742-287-04) / .3 mL in 1 CONTAINER
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A216533
AT3AT3
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": "50742-287_a6586769-4fb8-41df-bfd6-0971090ab79b",
"productndc": "50742-287",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "216533",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT3",
"strength": "EQ 0.25% BASE",
"product_no": "001",
"approval_date": "Sep 13, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AT3",
"strength": "EQ 0.5% BASE",
"product_no": "002",
"approval_date": "Sep 13, 2022"
}
],
"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": "ANDA216533",
"marketing_category": "ANDA",
"nonproprietary_name": "timolol maleate",
"start_marketing_date": "20220915",
"active_numerator_strength": "3.4"
}Related drugs
Other records sharing ATC code C07AA06.
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