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United States · US · US:68682-045_4fe86cd0-e1e4-e99c-e063-6294a90a2f03
Timolol Maleate
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168682045251 BOTTLE, DROPPER in 1 CARTON (68682-045-25) / 2.5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
N021516
AT2
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": "68682-045_4fe86cd0-e1e4-e99c-e063-6294a90a2f03",
"productndc": "68682-045",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "021516",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT2",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Jun 4, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "Timolol Maleate",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021516",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Timolol Maleate",
"start_marketing_date": "20180530",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA06.
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