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United States · US · US:69918-601_6d7e1321-5e22-4c03-bee1-4713d0ebc2d8
Timoptic in Ocudose
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNordic Pharma, Inc.
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11699186016060 POUCH in 1 CARTON (69918-601-60) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
A212592
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": {
"16323b0e-78ae-40e5-be93-04f698dd672b": {
"match": "brand_token",
"title": "TIMOPTIC IN OCUDOSE (TIMOLOL MALEATE) SOLUTION [NORDIC PHARMA, INC.]",
"spl_version": "6",
"published_date": "2026-06-01"
}
},
"productid": "69918-601_6d7e1321-5e22-4c03-bee1-4713d0ebc2d8",
"productndc": "69918-601",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "212592",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT3",
"strength": "EQ 0.25% BASE",
"product_no": "001",
"approval_date": "Dec 13, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AT3",
"strength": "EQ 0.5% BASE",
"product_no": "002",
"approval_date": "Dec 13, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "Timoptic in Ocudose",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212592",
"marketing_category": "ANDA",
"nonproprietary_name": "Timolol Maleate",
"start_marketing_date": "20220226",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA06.
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