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United States · US · US:62332-546_23d94ead-288f-4771-983c-7cf04363976a
Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162332546051 BOTTLE in 1 CARTON (62332-546-05) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A212942
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": "62332-546_23d94ead-288f-4771-983c-7cf04363976a",
"productndc": "62332-546",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "212942",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.25% BASE",
"product_no": "001",
"approval_date": "Oct 22, 2020"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5% BASE",
"product_no": "002",
"approval_date": "Oct 22, 2020"
}
],
"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": "ANDA212942",
"marketing_category": "ANDA",
"nonproprietary_name": "Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%",
"start_marketing_date": "20201122",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA06.
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