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United States · US · US:72603-163_1e9cae2e-e3bf-9a9d-22cc-c4a037e47409
Timolol Maleate Ophthalmic Gel Forming Solution 0.5%
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172603163011 BOTTLE in 1 CARTON (72603-163-01) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A215733
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": "72603-163_1e9cae2e-e3bf-9a9d-22cc-c4a037e47409",
"productndc": "72603-163",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "215733",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.25% BASE",
"product_no": "001",
"approval_date": "Sep 22, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5% BASE",
"product_no": "002",
"approval_date": "Sep 22, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "Timolol Maleate Ophthalmic Gel Forming Solution 0.5%",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215733",
"marketing_category": "ANDA",
"nonproprietary_name": "Timolol Maleate Ophthalmic Gel Forming Solution 0.5%",
"start_marketing_date": "20230814",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA06.
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